Thesis - Nazar

SMIMS
SIKKIM
NATIONAL MANIPAL
BOARD OF UNIVERSITY
EXAMINATIONS SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
Cover Page
A Prospective Interventional Study to C ompare

T-tube placement and Primary C losure of
Common Bile Duct in Patients Undergoing
Choledocholithotomy .
THESIS
FOR THE DEGREE
OF
DIPLOMATE NATIONAL BOARD
(GENERAL SURGERY)
NATIONAL BOARD OF EXAMINATIONS

2016-2019
Dr. Md Nazar Imam

Registration No.: 112-40101-161-208676
DNB resident
Department of Surgery
Sikkim Manipal Institute of Medical Sciences
Gangtok, Sikkim
Details of Thesis
Topic: A prospective interventional study to compare the T-tube

placement and primary closure of common bile duct in
patients undergoing choledocholithotomy.
Course: DNB (General Surgery)
Duration of
study: 1st January 2017 to 30th April 2018
Type of
study: Prospective
Institution: Sikkim Manipal Institute of Medical Sciences, Gangtok
Board: National Board of Examination, New Delhi
Student: Dr. Md Nazar Imam
Guide: Dr Labanya Charan Choudhury, MS
Professor and Head of Department

Department of General Surgery,
Sikkim Manipal Institute of Medical Sciences,
Gangtok, Sikkim - 737102.
Co-guide: Dr Kumar Nishant , DNB
Associate Professor
Sikkim Manipal Institute of Medical Sciences,
Gangtok, Sikkim - 737102.
.
I
III
Certificate
This is to certify that the work contained in this thesis entitled “A Prospective,
interventional study to compare the T tube placement and primary closure of Common
Bile Duct in patients undergoing Choledocholithotomy” for the degree of Diplomate of
National Board (General Surgery) has been carried out independently by Dr. Md Nazar
Imam in the Department of General Surgery, Sikkim Manipal Institute of Medical Sciences,
Gangtok, Sikkim, under the guidance of Dr Labanya Charan Choudhury along with direct
supervision of Dr. Kumar Nishant.
He has fulfilled all the conditions and pre-requisites of National Board of Examination, New
Delhi for the preparation and completion of this thesis for the degree of Diplomate of
National Board in General Surgery.
Date: __________________________________
DEAN
Air Marshal (Retd.) Dr. G. S. Joneja, MS
Professor of Obstetrics and Gynaecology
Gangtok, Sikkim Head of the Institution
IV
Certificate
Gangtok, Sikkim, under my guidance along with direct supervision of Dr. Kumar Nishant.
He has fulfilled all the conditions and pre-requisites of National Board of
Examination, New Delhi for the preparation and completion of this thesis for the degree of
Diplomate of National Board in General Surgery.
: Head of the Department

Date:
Dr. L. C. Chaudhary, MS
Head of the Department and Guide
Sikkim Manipal Institute of Medical Sciences, Gangtok.
V
Certificate
Gangtok, Sikkim, under my supervision along with guidance of Dr. L. C. Chaudhary
He has fulfilled all the conditions and pre-requisites of National Board of
Examination, New Delhi for the preparation and completion of this thesis for the degree of
Diplomate of National Board in General Surgery.
Date:
____________________________________
Co- Guide
Dr. Kumar Nishant, DNB
Associate Professor
Department of Surgery
Gangtok, Sikkim
VI
Declaration
The work contained in this thesis titled, “A Prospective, interventional study to

compare the T tube placement and primary closure of Common Bile Duct in patients
undergoing Choledocholithotomy“ for the degree of Diplomate of National Board (General
Surgery) has been Carried out independently by me in the Department of General Surgery,
Sikkim Manipal Institute of Medical Sciences, Gangtok, Sikkim, under the guidance of Dr. L.
C. Chaudhary and direct supervision of Dr. Kumar Nishant .
I also declare that the contents of this dissertation in part or in full have not been
submitted to any other institution or university for the award of any degree or diploma.
Date:
Dr. Md Nazar Imam
VII
Acknowledgement
I wish to take the opportunity to thank a number of people whose assistance has been
instrumental in the studies associated with this dissertation.
I am highly indebted to Dr. L. C. Chaudhary, MS, Professor and Head, department of
Surgery, Central Referral Hospital, SMIMS, Gangtok. Within his busy schedule of
engagements, he has made generous room, to make himself always available to instruct
me at every stage of this study as Guide. He has been a constant source of inspiration.
Without him this study wouldn’t have been possible.
I am deeply indebted to Dr. Kumar Nishant, DNB, Associate Professor, CRH who
supported me throughout this dissertation study as Co-Guide. He has always been a
standing inspiration and I am highly grateful for his continuous support, encouragement,
critical and constructive feedback during my candidature. He not only taught me the art of
surgery but also the finer details of holistic patient care. He took great pains to lead me
through every stage of this study. I will really be indebted for the precious time he managed
to dispend on this study.
I wish to pay special thanks to Air Marshal (Retd) Dr. G.S.Joneja, MS, Dean,
SMIMS Gangtok, for his generous support during this training period.
I take this opportunity to express my deep gratitude to Dr. Bikram Kharga, DNB,
MCh, Associate Professor, Department of Surgery, Dr. Phuchungla Bhutia, MS, Assistant
Professor, Department of Surgery for their constant and continuous encouragement, moral
support during this study and my entire training period. I greatly appreciate the trust, the
insightful discussion, offering valuable advice, during the whole period of the study, and
especially for their patience and guidance during the writing process. They always managed
to buoy my spirits whenever I felt anxious or desperate.
I would also like to thank Dr. Ezzat Khalda, MD, Assistant Professor, Department of
Radiology for their indispensable help and time required for the sonological assessment of
the patients during the period of this study.
VIII
I wish to thank my seniors Dr.Khasanvis Vishal, Dr. Soumya Pattnaik, Dr. Sahiraj
Singh, Dr. Ravi Ranjan for providing a good atmosphere in our department and for useful
discussions. They were always around me to ensure smoothness of my project.
I would also like to thank the nurses and staff of the male, female surgery wards and
the surgery OPD, and also the staff of the Department of Radiology for their helpful services
which led to the smooth conduct of this study.
Lastly, I would like to thank my family members for their support during the highs
and lows of my life.
- Md Nazar Imam
-
IX
Table of contents
DETAILS OF THESIS ...............................................................................................................
CERTIFICATES .....................................................................................................................
CERTIFICATES .....................................................................................................................
INTRODUCTION ...................................................................................................................
AIM AND OBJECTIVE .............................................................................................................
REVIEW OF LITERATURE .........................................................................................................
PATIENTS AND METHOD ...................................................................................................
OBSERVATIONS...................................................................................................................
DISCUSSION .......................................................................................................................
SUMMARY.........................................................................................................................
MASTERCHART ........................................................................ ERROR! BOOKMARK NOT DEFINED.
ANNEXURES .......................................................................................................................
BIBLIOGRAPHY....................................................................................................................
X
List of tables
S Page
Table description
no no
Comparison of demographic parameter between the two study groups
1 60
(N=32)
Comparison of group with clinical presentation of study population
2 61
(N=32)
3 Comparison of group with Co-morbidities of study population (N=32) 62
Comparison of pre-operative hematological parameters between the two
4 62
study groups (N=32)
Comparison of mean value of pre-operative liver function parameter
5 63
between the two groups (N=32)
6 Comparison of mean value in group between USG finding (N=32) 64
7 Comparison of group with MRCP finding of study population (N=32) 65

Comparison of total duration of the surgery (minutes) between the two
8 66
study groups (N=32)
Comparison of total and direct bilirubin 72 hours post-operatively
9 67
between the two study groups (N=32)
Comparison of value of alkaline phosphatase between the two groups 72
10 68
hours post-operatively (N=32)
11 Comparison of drain output (ml) between the two study groups (N=32) 69
12 Comparison of time to drain removal between the two groups (N=32) 70

Comparison of group with post-operative nausea vomiting (N=32)
13 70
Comparison of median value of pain (visual analog scale) between the two
14 71
groups (N=32)
15 Comparison of group with wound cellulitis of study population (N=32) 72
16 Comparison of duration of hospital stay between the two groups (N=32) 72
17 Comparison of hospital expenses between the two study groups (N=32) 73
18 Comparison of outcome variables in the present study with other studies 82
XI
List of figures
Page
S. no FIGURE DESCRIPTION
no
1 Anatomy of common bile duct 13
2 Common bile duct and its divisions 14
3 Relation of common bile duct with adjacent organs 15
4 Bar chart of comparison of age between the two study groups (N=32) 60
Stacked bar chart comparing of gender distribution between the two
5 60
study groups (n=32)
6 Bar chart of comparison of BMI between the two study groups (N=32) 60
Comparison of pre-operative hemoglobin and TLC between the two
7, 8 62
study groups (N=32)
9,10,11 Comparison of mean values of LFTs between the two groups (N=32) 63
Pie chart of comparison of mean common bile duct diameter (mm) on
12 64
USG between the two groups (N=32)
Pie chart of comparison of mean common bile duct diameter (mm) on
13 65
MRCP between the two study groups (N=32)
Bar chart of comparison of total duration of the surgery (minutes)
14 66
Bar chart of comparison of post - operative total bilirubin 72 hr
15,16 67
Bar chart of comparison of mean value of post-operative alkaline
17 68
phosphatase between the two groups (N=32)
Trend line diagram of comparison of drain output between the two
18 69
groups (N=32)
Comparison of the mean ‘time to drain removal’ (days) between the
19 70
two study groups (N=32)
Bar chart of comparison of median value of pain (visual analog scale)
20 71
21 Comparison of wound cellulitis between the two groups (N=32) 72
Comparison of mean post - operative hospital stay in (days) between
22 73
the two study groups (N=32)
Bar chart of comparison of hospital expenses rupees between the two
23 73
study groups (N=32)
XII
List of abbreviations
Glossary Abbreviations
CBD Common bile duct
CBDS Common bile duct stones
CI Confidence interval
EBD External biliary drainage
CBDE Common bile duct exploration
LCBDE Laparoscopic common bile duct exploration
PTCD Percutaneous transhepatic cholangiography drainage
RaR Rate ratio
RevMan Review Manager
TTF T-tube free
TTD T-tube drainage
MD Mean difference
RR Risk ratio
ERC Endoscopic retrograde cholangiography
USG Ultrasonography
PC Primary closure
LC Laparoscopic cholecystectomy
OR Odds ratio
MRCP Magnetic resonance cholangiopancreatography
XIII
Introduction
XIV
Introduction
The liver is the largest gland in the human body occupying 2.5% of total body weight
and providing a host of functions necessary for maintaining normal physiological
homeostasis1. The liver is a large lobed glandular organ situated in the abdomen which is
responsible for detoxification, metabolism, synthesis and storage of various substances.
Despite the complexity of its functions, the liver has a homogenous appearance. Of all the
functions of the liver, bile production is one of the most important2. Biliary function results
from the sequential vectorial transport of endogenous and exogenous substrates through
three compartments: the vascular space, cellular space and biliary space. Bile is a lipid-rich
hepatic secretion3 that is necessary for elimination of cholesterol and xenobiotics from the
body and for dispersion and efficient absorption of digested dietary lipid in the upper small
intestine. Bile is necessary for digestion of fat and removal of certain waste byproducts
from the liver. The bile produced in the liver is stored temporarily in the gallbladder. On
eating fatty food, the gallbladder releases the bile into the small bowel. The common bile
duct is the tube through which bile flows from the gallbladder to the small bowe1.
Stones can obstruct the flow of bile from the gallbladder into the small
bowel. Choledocholithiasis is the development of stones in the common bile duct. It
develops in about 10–15% of patients with gallbladder stones4 and literature suggests that
common bile duct stones are encountered in approximately 7–15% of patients undergoing
cholecystectomy5. Usually such stones are formed in the gallbladder and migrate into the
common bile duct. Obstruction to the flow of bile can lead to jaundice. Such stones are
usually removed by inserting an endoscope before keyhole removal of gallstones
(laparoscopic cholecystectomy), or as a part of keyhole removal of gallstones (laparoscopic
common bile duct exploration). Endoscopic removal of the common bile duct stone is the
commonly used method to treat stones in the common bile duct where facilities are
available.
Traditionally, a T-tube through the cut in the common bile duct is used 6, 7, 8.
The top horizontal portion of the 'T tube' is inside the common bile duct while the long
vertical bottom part is brought out of the abdomen and connected to an external bag for
drainage. The cystic duct is sealed if the exploration is done through it. In addition to acting
as a drain, which drains the bile from the common bile duct to the exterior, dye can be
injected into the T-tube and an X-ray used to demonstrate any residual stones. Once the
absence of residual stones is confirmed, the T-tube is removed. The build-up of bile along
with the swelling can potentially prevent the healing of the bile duct resulting in a leakage
1
Introduction
of bile from the common bile duct into the abdomen. Uncontrolled bile leak can be
potentially life-threatening if not recognized and treated.
The tiny hole left after T-tube removal in the common bile duct normally
heals without a trace but, bile can leak through this hole raising the questions of the use of
a T-tube after laparoscopic common bile duct exploration.
There are numerous reports of complications specifically associated with
the use of a T-tube for biliary drainage9, 10. These occur after both open and laparoscopic
exploration of the CBD. In general, complications include: fluid and electrolyte
disturbances, sepsis, premature dislodgement, bile leak, localised pain, biliary peritonitis,
prolonged biliary fistulae and late biliary stricture. It is important to note that the presence
of a T- tube does not prevent bile leaks as they occur both when it is still in situ, as well as
after its removal11,12. Previous studies comparing primary closure with T-tube drainage in
open techniques13 showed a significant reduction in hospital stay and duration of operation
with comparable complication rates. Subsequently, Wu and Soper et al14, in a prospective
randomised experimental animal study of different laparoscopic techniques of exploration
and closure of the CBD, showed similar reduction in operating time. They also reported that
primary closure of the CBD resulted in a significant increase in stenosis.
The need for this arises because the question still remains whether T-tube
drainage is better than primary closure after laparoscopic exploration of common bile duct
in Indian settings in terms of efficacy, safety and feasibility although laparoscopic common
bile duct exploration are performed only in highly specialized centers, using instruments or
a camera, or both, which are introduced into the common bile duct usually through a cut
in the common bile duct.
So we carried out our study with the objective of comparing the efficacy, safety and
feasibility of primary closure of common bile duct and T-tube drainage in patients
undergoing choledocholithotomy.
2
AIM AND OBJECTIVE
Aims and objective
Primary objective:
To assess feasibility of safe primary closure in order to achieve early discharge and
define case selection for this purpose.
Null hypothesis (H₀): Primary closure of common bile duct after open
choledocotomy is feasible and is as safe as T-tube insertion.
Secondary objectives:
The following objectives were compared between the two groups (primary CBD
closure of T-tube closure):
i. The duration of surgery

ii. Biochemical level of liver function test before and 72 hours post-operatively
iii. Post-operative complications – drain output (biliary leak), acute pancreatitis,
delayed biliary peritonitis, wound Infection
iv. Hospital expenses
4
REVIEW OF LITERATURE
Review of literature
Historical review
GALL-STONE DISEASE
Though the gall bladder has been known since ancient times, its structure and
function had eluded us till a couple of centuries ago. Moreover gallstones have afflicted
mankind since prehistoric times. This evidenced by the discovery of gall stones in several
mummies. The excavations in Mycenia , in 1841, unearthed several cholesterol calculi in
the skeletal remains of a 50 year old man, dating back to 1600- 1500 BC, which slightly
antecedes the gallstones found in priestess of Amenen of the 21st Egyptian dynasty dating
back to 1500 BC15.
The earliest description of gallstones can be found in Alexandri Yatros Practica

(Twelve Books on Medicine: chapter 2 of book VIII), the work of a Greek physician
Alexander Trallianus (525 to 605 AD), who described them as concretions in the liver16,17.
Another account of gallstones is found in the articles written by Rhazes, about 900
AD, where he had mentioned that alcheron lapis, as called by the then philosophers, was a
ring shaped stone found in bile of ox and believed to have medicinal value in epilepsy and
eye disorders. In 1317 Matthaeus Sylvaticus mentioned gallstones in his book Liber
Pandectarum Medicinae.
In humans, Gentile da Foligno in Padua (Italy) first described gallstones in 1341, who
noted many stones within the post-mortem specimen of gall bladder18.
Antonio Benevieni in 1420 described gallstones in a woman who died of biliary colic
and was probably the first person who mentioned ‘Gall Bladder’: “stones hanging down in
a sac formed by the membrane covering the liver”19.
Andreas Vesalius (in his epistolary treatise: 'Radicis Chinae Usus’ in 1546) had given
many illustrations regarding gallstones and it is his book where we can find first instance of
observation regarding obstruction to ducts connecting gall bladder to liver and intestine
(cystic and hepatic duct).
Gabrielis Fallopia, in his book, Gabrielis falloppii Medici Mutinensis Observationes

Anatomicae, had told that the duct leading from liver to intestine is the least allowed place
7
for the stone to be found (1523-1562). In his other book, Tractatus de fossilibus, we find
the first instance where someone has tried to explain nature and formation of gallstones20.
CHOLEDOCHOLITHIASIS
Historical aspects of the management of bile duct stones have been reviewed by
Morgenstern21. The first cholecystectomy has been attributed to Dr. Karl Langenbuch, a
surgeon in Berlin, in 1882.Within a decade, cholecystectomy was being combined with
exploration of the bile duct in selected patients with jaundice or cholangitis. By 1900,
additional surgical procedure had been described including cholecystoto-enterostomy and
operative sphincteroplasty. At similar time, operative drainage of bile duct using T-tube
was described by another German surgeon, Dr. Hans Kehr.
The first description of operative choangiography has been attributed to Dr. Mirizzi
in Argentina. This procedure increased the detection of unsuspected bile duct stones and
decreased the frequency of unnecessary bile duct explorations. Although rigid
choledochoscopy had been described in the 1940s, it was not until the 1960s that optical
systems were good enough to promote their widespread use22
Another major step forward was introduction of endoscopic retrograde

cholangiopancreatography and endoscopic sphincterotomy.Subsequently sphincteotomy
became a common procedure for patients with bile duct stones prior to cholecystectomy
and became the procedure of choice for removal of bile duct stones after cholecystectomy.
Common bile duct stone disease

EPIDEMIOLOGY
The term choledocholithiasis refers to a condition when a gallstone or gallstones

become lodged within any duct of the bile system. The ducts typically involved are the
common bile duct, the cystic duct, and the common hepatic duct. Choledocholithiasis is
commonly used to refer to the presence of a gallstone in the common bile duct. It is also
known as bile duct stones or gallstones in the bile duct23. Choledocholithiasis develops in
about 10–15% of patients with gallbladder stones4 and literature suggests that common
8
bile duct stones are encountered in approximately 7–15% of patients undergoing

cholecystectomy5.
Common Bile Duct Stones are one of the medical conditions leading to surgical
intervention occurring in 3%–14.7% of all patients for whom cholecystectomies are
performed24. When patients present with CBD, the important question is the best modality
of treatment available with regard to diagnostic performance characteristics, technical
success, safety, and cost effectiveness.
Gallstone disease remains one of the most common medical problems leading to
surgical intervention. Every year, approximately 500,000 cholecystectomies are performed
in the United States24. Cholelithiasis affects approximately 10% of the adult population in
the United States24. Reliable national level data is not available from India regarding the
exact burden of gall stones. But Northern region of India is reported to one of the high risk
geographical regions for occurrence of gall stones and other spectrum of gall bladder
disorders, including gall bladder cancer. Hospital-based reports in north India showed a
higher incidence: Varanasi 13.44% asymptomatic GBD and 11.14% cholelithiasis 25 ;
Chandigarh gallstone 3.3% asymptomatic and 64.9% symptomatic 26 ; and New Delhi
gallstone disease 29.8%27. A referral bias or higher prevalence associated with urban life
style could be the reason in urban hospital-based registries. The prevalence rates for GST
in this survey were similar to another smaller survey in Kashmir28; women 9.6% and men
3.07%
It has been well demonstrated that the presence of gallstones increases with age.
An estimated 20% of adults over 40 years of age and 30% of those over age 70 have biliary
calculi. During the reproductive years, the female-to-male ratio is about 4:1, with the sex
discrepancy narrowing in the older population to near equality. The risk factors
predisposing to gallstone formation include obesity, diabetes mellitus, oestrogen and
pregnancy, haemolytic diseases, and cirrhosis. Approximately 35% of patients initially
diagnosed with having, but not treated for, gallstones later developed complications or
recurrent symptoms leading to cholecystectomy. During the last two decades, the general
principles of gallstone management have not notably changed. However, methods of
9
treatment have been dramatically altered. Today, laparoscopic cholecystectomy,

laparoscopic common bile duct exploration, and endoscopic retrograde management of
common bile duct (CBD) stones play important roles in the treatment of gallstones. These
technological advances in the management of biliary tract disease are not infrequently
accomplished by a multidisciplinary team of physicians, including surgeons trained in
laparoscopic techniques, interventional gastroenterologists, and interventional
radiologists. With the evolution of laparoscopic cholecystectomy, there has been a global
re-education and retraining program of surgeons. However, the treatment of choice for
gallstones remains cholecystectomy. Gross and compositional analysis of gallstones allows
them to be classified as cholesterol, mixed, and pigment gallstones. When asymptomatic
gallstones are detected during the evaluation of a patient, a prophylactic cholecystectomy
is normally not indicated because of several factors. Only about 30% of patients with
asymptomatic cholelithiasis will warrant surgery during their lifetime, suggesting that
cholelithiasis can be a relatively benign condition in some people. However, there are
certain factors that predict a more serious course in patients with asymptomatic gallstones
and warrant a prophylactic cholecystectomy when they are present. These factors include
patients with large (>2.5 cm) gallstones, patients with congenital haemolytic anaemia or
non-functioning gallbladders, or during bariatric surgery or colectomy. Epigastric and right
upper quadrant pain occurring 30-60 minutes after meals is frequently associated with
gallstone disease. The diagnosis of chronic cholecystitis is made by the presence of biliary
colic with evidence of gallstones on an imaging study. Ultrasonography is the diagnostic
test of choice, being 90-95% sensitive. The surgical literature suggests that 3-10% of
patients undergoing cholecystectomy will have CBD stones.
RISK FACTORS
Genetic and environmental factors contribute to gallbladder disease. Female

gender, previous pregnancies, and family history of gallstone disease are highly correlated
with cholelithiasis 29 30 31 . Approximately 60% of patients with acute cholecystitis are
women; however, the disease tends to be more severe in men29 30 31. Oestrogen increases
10
cholesterol and its saturation in bile and promotes gallbladder hypomotility. Diminished
gallbladder motility is commonly seen during pregnancy. Other risk factors include a high
dietary intake of fats and carbohydrates, a sedentary lifestyle, type 2 diabetes mellitus, and
dyslipidaemia (increased triglycerides and low HDL).3 9 A diet high in fats and carbohydrates
predisposes a patient to obesity, which increases cholesterol synthesis, biliary secretion of
cholesterol, and cholesterol hypersaturation. However, a direct correlation between high
dietary intake of fats and cholelithiasis risk has not been established because previous
studies have yielded controversial results. Acute cholecystitis develops more frequently in
symptomatic cholelithiasis patients with type 2 diabetes mellitus than in symptomatic
patients without it. These patients also are more likely to have complications. American
Indians have the highest prevalence of cholelithiasis, with the disease reaching epidemic
proportions in this population. Gallstone disease is also prevalent in Chilean and Mexican
Hispanics. In addition to ethnicity, age plays a role in gallstone disease. Patients who
develop complicated symptomatic cholelithiasis tend to be older, and the typical patient
with gallstones is in her forties.
CLINICAL PRESENTATION
Gallstones are generally asymptomatic. In the uncommon event that a patient

develops symptomatic cholelithiasis, presentation can range from mild nausea or
abdominal discomfort to biliary colic and jaundice32 33. Biliary colic, usually sharp in nature,
is postprandial epigastric or right-quadrant pain that lasts for several minutes to several
hours. The pain often radiates to the back or the right shoulder, and in more intense cases
it may be accompanied by nausea and vomiting. Upper-right-quadrant tenderness and
palpable infiltrate in the region of the gallbladder are revealed upon physical examination.
Cholecystitis presents in the same manner; however, the obstruction of the cystic duct is
persistent (rather than transient), and fever is common. A patient with cholecystitis also
may exhibit Murphy’s sign (discomfort so severe that the patient stops inspiring during
palpation of the gallbladder) or jaundice32 33. Jaundice, a yellow discoloration of the skin
and the sclera of the eyes, occurs when the common bile duct is obstructed because of an
impacted stone in Hartmann’s pouch (Mirizzi’s syndrome). Other nonspecific symptoms,
11
such as indigestion, intolerance to fatty or fried foods, belching, and flatulence, may also
be present.
Common bile duct

GROSS ANATOMY
The common bile duct is formed at the junction of the common hepatic duct with
the cystic duct. At adults, the length was between 55–150 mm and the diameter between
4–14 mm, for males, and the length was between 50–95 mm and the diameter between
4–8 mm, for females34 35.
The average length and

the average diameter of the
common bile duct are larger in
males. The common bile duct
presents a series of anatomical
variations regarding its course
and relations. Those
peculiarities are important
because they should be known
by the surgeons during the
Figure 1: Anatomy of common bile duct
surgery of the gallbladder,
pancreas and duodenum.
Continuing the course of the hepatic duct, the common bile duct has an arciform
course with a right and anterior concavity, going to the descending segment of the
duodenum where, after the joining with the main pancreatic duct, it will open on the
hepato-pancreatic ampulla, in the middle third of this duodenal segment. The common
bile duct consists of three parts: retro-duodenal, retro-pancreatic and intra-parietal.
12
Figure 2: Common bile duct and its divisions
1. Bile ducts 12. Spleen.

2. Intrahepatic bile ducts, 13. Esophagus.
3. Left and right hepatic ducts, 14. Stomach.
4. Common hepatic duct, 15. Pancreas:
5. Cystic duct, 16. Accessory pancreatic duct,
6. Common bile duct, 17. Pancreatic duct.
7. Ampulla of Vater, 18. Small intestine:
8. Major duodenal papilla 19. Duodenum,
9. Gallbladder, 20. Jejunum
10–11. Right and left lobes of liver 21–22. Right and left kidneys.
The front border of the liver has been lifted up (brown arrow).
Figure 3: Relation of common bile duct with adjacent organs
13
The supra-duodenal segment
The supra-duodenal segment founded in the right border of the lesser omentum is
a part of the hepatic pedicle. In this case, the supra-duodenal segment has posterior
relations with the portal vein, via a thin layer of connective tissue. This layer, in pathological
cases, can compromise the separate one of the two structures, with the possible damage
of the portal vein. On the left side of the common bile duct arises the proper hepatic artery.
The retroduodenal segment
The retroduodenal segment is a part of the anterior wall of the Winslow’s hiatus.
The common bile duct descends posterior to the superior segment of the duodenum, in
relation with the superior duodenal flexure, and describes an arch with anterior concavity.
This segment has important vascular relations : the portal vein, posterior; the common
hepatic artery, on the left side of the common bile duct and it will continue with the proper
hepatic artery; gastroduodenal artery, which descends anterior to the portal vein and to
the left of the common bile duct. At this level, the superior right pancreatico-duodenal
artery, with origin in the gastro-duodenal artery, crosses the anterior side of the common
bile duct, over the pancreas. Then, it passes on the dorsal side of the pancreas, between
the common bile duct and the second segment of the duodenum, and ends with an
anastomosis with the superior branch of the left pancreatico-duodenal artery; the superior
right pancreatico- duodenal artery passes posterior to the common bile duct and opens on
the right side of the portal vein. The portal vein is passing through the triangle forms by
the superior border of the pancreas, the common hepatic artery to the left and the gastro-
duodenal artery to the right. In this triangle and on the left side of the common bile duct
there are present one or two lymph nodes. There, it is also present the end of the gastric
coronary vein, which passes downward and it opens in the portal or splenic vein.
The retropancreatic segment
The common bile duct descends through a groove or a canal placed on the posterior
side of the pancreas. In this segment, the common bile duct is related to the pancreas
anteriorly.
14
The superior posterior-

pancreatico-duodenal artery or
superior right pancreatico-
duodenal artery passes anterior
to the common bile duct from left
to right, and descends wrapping
around the CBD, and then passes
Figure 4: Relations of the retro-pancreatic common
posterior to it to reach the (posterior view)
uncinate process.
The retropancreatic common bile duct passes through Quénu space bordered by
the three segments of duodenum and the superior mesenteric vein and the portal vein.
Together with the head of the pancreas, the
retropancreatic segment of the common bile
duct will project at the level of the anterior
abdominal wall in an area with the following
borders: a vertical and a horizontal line which
form a straight angle with the tip at the level of
the umbilicus and which opens to the right. After
that, we place the bisecting line of this angle. The
projecting area is between the bisecting line and
the vertical line without touching the umbilicus. Figure 5: Projection of the distal bile duct on
the anterior abdominal wall
The papilla is about 5 cm from the umbilicus on
this line.
Intra-duodenal segment
Reaching the descending duodenum, the common bile duct passes through its
medial wall and will open together with the main pancreatic duct at the level of the hepato-
pancreatic ampulla. On its intra-duodenal course, the common bile duct elevates the
mucosa of the duodenum and forms the longitudinal fold of duodenum. In the inferior end
of this fold, there is a prominence – the major duodenal papilla where the hepato-
15
pancreatic ampulla is found. The duodenal mucosa covers the papilla like a hood. The tip
of the papilla is traced down by a fold called the frenulum, which is placed in a sagittal
plane. In adults the size of the major duodenal papilla was: length of 4–10 mm and a width
of 2–7 mm. In most of the cases, the common bile duct is opening at the level of the middle
third of the duodenum.
ULTRASTRUCTURE
With regards to structure and

microstructure36, the biliary tract, comprising the
bile duct and peribiliary glands, is anatomically
divided into the extrahepatic and intrahepatic
biliary tree. The intrahepatic biliary tree is further
divided into large bile ducts, corresponding to the
right and left hepatic ducts and their first to third
order branches, and into septal and interlobular
Figure 7: Ultrastructure of bile ducts
bile ducts and bile ductules according to their size
and location relative to the hepatic lobules and surrounding structures. The right and left
hepatic ducts and the extrahepatic bile ducts are composed of dense fibrous duct walls
lined by a layer of columnar biliary epithelium. The peribiliary glands, which may secrete
mucinous and serous substances into the bile, are found along the extrahepatic and large
intrahepatic bile ducts. They are divided in glands within and outside the duct wall. The
former (intramural glands) drain directly into the lumen of the bile duct, while the latter
(extramural glands) are composed of several
lobules and drain into the ductal lumen via
their own conduits. The biliary tract is
supplied by a complex vasculature called the
peribiliary vascular plexus. Afferent vessels
of this plexus derive from hepatic arterial
branches, and this plexus drains into the
Figure 6: The peribiliary vascular plexus (cast
electron micrograph) portal venous system or directly hepatic
16
sinusoids. The development of the intrahepatic biliary tract is divided into three stages: the
stage of the ductal plate, the stage of biliary cell migration into the mesenchyme, and the
stage of bile duct formation in the portal tract.
Presentation and complication of choledocholithiasis***

PRESENTATION
Bile is necessary for digestion of fat and removal of certain waste by-products from
the liver37. The bile produced in the liver is stored temporarily in the gallbladder. On eating
fatty food, the gallbladder releases the bile into the small bowel. The common bile duct is
the tube through which bile flows from the gallbladder to the small bowel1. Stones can
obstruct the flow of bile from the gallbladder into the small bowel. Usually such stones are
formed in the gallbladder and migrate into the common bile duct. Obstruction to the flow
of bile can lead to jaundice. Such stones are usually removed by inserting an endoscope
before keyhole removal of gallstones (laparoscopic cholecystectomy), or as a part of
keyhole removal of gallstones (laparoscopic common bile duct exploration) 37. Bile acids,
synthesized by hepatocytes from cholesterol38, are specific and quantitatively important
organic components of bile, where they are the main driving force of the osmotic process
that generates bile flow toward the canaliculus. Of all the functions of the liver, Bile
Production is one of the most important2. Biliary function results from the sequential
vectorial transport of endogenous and exogenous substrates through three compartments:
the vascular space, cellular space and biliary space. Bile is a lipid-rich hepatic secretion3
that is necessary for elimination of cholesterol and xenobiotics from the body and for
dispersion and efficient absorption of digested dietary lipid in the upper small intestine.
Bile is an isoosmotic electrolytic fluid that is formed in the liver and is a product of its
secretory function. Bile is primarily secreted by hepatocytes (i.e., canalicular bile) and
subsequently delivered to the intrahepatic bile ducts, where it is modified by
cholangiocytes (i.e., ductal bile). Bile secretion by liver parenchymal cells is the result of
vectorial transcellular transport of solutes and involves the coordinated action of transport
proteins at the basolateral (sinusoidal) and apical (canalicular) membranes of the
hepatocyte39. A complex network of signals controls uptake and efflux transporters on a
17
long- and short-term timescale, including regulation at the level of gene transcription,
protein translation and maturation, covalent modification, and dynamic localization of
transporter proteins, as well as substrate availability. Bile contains almost all body
components: proteins, lipids, carbohydrates, vitamins, mineral salts, and trace elements 2.
The greater part of the bile proteins consists of globulins, and the lesser part comprises
albumins. Phospholipids, cholesterol and its esters, neutral fats, and fatty acids rank high
among bile lipids. Lecithins (phosphatidylcholines, PCs) are the major representatives of
bile phospholipids. They are synthesized in the liver from the same components as plasma
PCs; however, they differ from the latter in the higher content of palmitic acid. The human
bile concentration of free fatty acids and α-monoglycerides is small. Human cystic bile
shows small quantities of diglycerides and is virtually free of triglycerides. The electrolyte
content of bile is similar to that of plasma. The major cations are sodium, potassium, and
calcium; the anions are chloride and bicarbonate. The bile content of sodium is about 10
times higher than that of potassium. Excretion of sodium, potassium, and calcium into the
bile is closely related to the rate of metabolic processes in the liver and depends on its
functional state and on the content of salts in the body. The bile concentration of anions is
5-15 times smaller than that of cations. A deficit of anions is compensated for by
taurocholate. Bile contains a considerable quantity of phosphorus, magnesium, iodine,
iron, and copper. The relative proportions of the major bile components are distributed in
the following order: bile acids (67%), phospholipids (22%), proteins (4.5%), cholesterol
(4%), and bilirubin (0.3%). Among the bile acids, the primary bile acids, cholic and
chenodeoxycholic acids in a ratio of 1:1, account for about 50%. These are followed by the
secondary bile acids, deoxycholic and lithocholic acids, as well as ursodeoxycholic and
sulfolithocholic acids in the decreasing order.
Gallstones can range from being microscopic to the size of a golf ball. Some people
affected by gallstones may only have one or two, whereas others may have hundreds of
stones within their gallbladder.
The pathogenesis of stone formation is divided into three phases:
 supersaturation,
18
 nucleation and
 stone growth.
Hypersecretion of biliary cholesterol, crystallization promoting and inhibiting

factors, gallbladder hypomotility, arachidonyl lecithin, prostaglandins, mucin and calcium
play an important role in the formation of gallstones. For the formation of pigment stones
a decreased secretion of biliary acids, an increased secretion of unconjugated bilirubin into
the bile and an infection of the biliary tract are the most important causative factors.
Gallstones may vary in cause and type. Traditionally, gallstones are divided into
three main types:
Pigment gallstones: These stones are typically brown pigment stones that form
within the bile ducts, such as the common bile duct. Pigment gallstones are made from a
substance found in the body called bilirubin.
Cholesterol gallstones: These yellow-green stones form within the gallbladder and
are usually made of cholesterol. Cholesterol gallstones are typically found in one of the bile
ducts after they have travelled from the gallbladder. These are the most common type of
gallstones found in developed countries.
Mixed gallstones: These gallstones are a combination of two or more substances,

including calcium, phosphate, protein, and cysteine.
They may also be classified as residual and recurrent common bile duct stones.
Residual CBD stones are those that are left behind after the removal of the gallbladder
(cholecystectomy). Typically, they are found within 3 years after a person has undergone
the procedure. Recurrent gallstones develop more than three years after
choledocholithotomy.
COMPLICATION
In some cases of gallstone disease a bile duct can become permanently blocked, which can
lead to a build-up of bile inside the gallbladder. This can cause the gallbladder to become
infected and inflamed
19
Sometimes a severe infection can lead to gallbladder abscess (empyema of the

gallbladder).
Infection of the bile ducts -acute cholangitis.
Acute pancreatitis may develop when a gallstone moves out of the gallbladder and blocks the
opening (duct) of the pancreas, causing it to become inflamed.
If a gallstone passes out of the gallbladder into the bile duct and blocks the flow of bile,
jaundice occurs.
Another rare but serious complication of gallstones is known as gallstone ileus.
Gallbladder cancer is a rare but serious complication of gallstones.
The pathogenesis of cholecystitis30 most commonly involves the impaction of

gallstones in the bladder neck, Hartmann’s pouch, or the cystic duct; gallstones are not
always present in cholecystitis, however5 pressure on the gallbladder increases, the organ
becomes enlarged, the walls thicken, the blood supply decreases, and an exudate may
form. Cholecystitis can be either acute or chronic, with repeated episodes of acute
inflammation potentially leading to chronic cholecystitis. The gallbladder can become
infected by various microorganisms, including those that are gas forming. An inflamed
gallbladder can undergo necrosis and gangrene and, if left untreated, may progress to
symptomatic sepsis. Failure to properly treat cholecystitis may result in perforation of the
gallbladder, a rare but life-threatening phenomenon. Cholecystitis also can lead to
gallstone pancreatitis if stones dislodge down to the sphincter of Oddi and are not cleared,
thus blocking the pancreatic duct. Due to the severity of these complications, it is important
for patients with choledocholithiasis to get treatment as soon as possible.
Management of choledocholithiasis
Choledocholithiasis develops in about 10–15% of patients with gallbladder stones4
and literature suggests that common bile duct stones are encountered in approximately 7–
15% of patients undergoing cholecystectomy5. Open exploration of the bile duct was the
principal treatment for almost 100 years. In some hospitals of developing countries,
20
surgeons are still performing this procedure because minimally invasive techniques like
ERCP are not available40. Choledocholithiasis, though seen in all age group, it is the ‘Fat,
Fertile, Flatulent, Female of Fifty’ that is most commonly affected. The incidence increases
with age.23 The incidence is also on the rise in this part of the country, possible reasons are
the changing dietary habits, increasing awareness of the health in people and
improvements in the imaging technology. The management of common bile duct stone is
constantly evolving. The traditional and standard line of management was laparotomy and
choledochotomy along with cholecystectomy. The classical performance of bile duct
exploration is associated with the problem of an incised bile duct closure. Choledochotomy
followed by T-tube drainage is a traditional surgical treatment for chloledocholithiasis.11
Although it is true that the T-tube has been used and has proven to be a safe and effective
method for postoperative biliary decompression, it is not exempt from complications,
which are present in up to 10% of patients.41 The most frequent of these is bile leakage
after removal, which is reported to occur in 1–19% of cases.10 13 42 43 Some of these
complications are serious, such as bile leak, tract infection or acute renal failure from
dehydration due to inadequate water ingestion or a very high outflow, particularly in
elderly patients. In addition, having bile drainage in place for at least 3 weeks causes
significant discomfort in patients and delays their return to work8,9,44.
Gurusamy KS et al concluded evidence was insufficient to recommend T-tube

drainage over primary closure after laparoscopic common bile duct stone exploration or
vice versa.45 The laparoscopic management of common bile duct stones is well known
these days,46 but remains controversial. This procedure is demands skills and equipment,
and is therefore used by few surgeons.47 Moreover, the superiority of this procedure for
the treatment of common bile duct stones has not yet been proven, which limits its
applicability42. Therefore open surgery is still a treatment of choice in many hospitals.
OPTIONS OF MANAGEMENT
Treatment of the bile duct stones can be conducted as open cholecystectomy plus
open common bile duct exploration or laparoscopic cholecystectomy plus laparoscopic
common bile duct exploration (LC + LCBDE) versus pre- or post-cholecystectomy
21
endoscopic retrograde cholangiopancreatography (ERCP) in two stages, usually combined

with either sphincterotomy (commonest) or sphincteroplasty (papillary dilatation) for
common bile duct clearance. There are mainly two methods for extracting common bile
duct stones48. Either endoscopically, by endoscopic retrograde cholangiopancreatography,
or surgically, by an open or laparoscopic method.
The introduction of endoscopic retrograde cholangiography and laparoscopic
cholecystectomy has become even more controversial. Newer options that have emerged
are chemical dissolution, extracorporeal lithotripsy and intracorporeal lithotripsy. Studies
done in the recent past show that surgery for common bile duct stones is an efficacious
option and can be carried out safely with acceptable morbidity and no mortality. Coagulum
choledocholithotomy is also found to be effective in a vast majority of patients49.With the
advent of laparoscopic era laparoscopic common bile duct exploration can be employed
successfully in majority of patients with common bile duct stones. Success rate is as high as
91.8% and is associated with minimal complications. Laparoscopic common bile duct
exploration is found to be as efficient and safe as endoscopic retrograde
cholangiopancreatography in achieving bile duct stone clearance.50
Mokarram Ali, M. D. et al observed that primary closure group had less operating
time, less duration of hospital stay and less complication rates as compared to T-tube group
and concluded that primary closure can be recommended as safe alternative procedure
after choledocholithotomy in selected patients of choledocholithiasis51. Ambreen M et al
concluded that primary common bile closure is a safe and cost effective alternative to
routine T-tube drainage after open choledocholithotomy 52 . Primary closure of the
common bile duct after exploration is not new. Halstead first described the advantages of
primary closure. There are many papers reported by different authors, which support the
direct closure of the duct immediately after exploration8 13 40 53 54 . With the help of a
choledochoscope during surgery, direct visualisation of the common bile duct is possible
and retained stones are not a problem. Traditionally, exploration of the common bile duct
both with open surgery and laparoscopically was accompanied with the placement of a T-
tube drain. The use of a T-tube following common bile duct exploration was based on three
main factors:
22
 The potential for extraction of retained stones with the aid of a steerable catheter.
 As a method of achieving a controlled biliary fistula.
 Easy access for radiological visualisation of the common bile duct.
Use of a choledochoscope enables direct visualisation of the common bile duct and ensures
its complete clearance as well as inspection of the distal common bile duct for other
possible causes of obstruction at the level of the sphincter of oddi. However, there are
numerous reports of complications specifically associated with the use of a T-tube for
biliary drainage. These occur after both open and laparoscopic exploration of the common
bile duct stones. In general, complications include: fluid and electrolyte disturbances,
sepsis, premature dislodgement, bile leak, localised pain, biliary peritonitis, prolonged
biliary fistulae and late biliary stricture. It is important to note that the presence of a T-
tube does not prevent bile leaks as they occur both when it is still in situ, as well as after its
removal11 12. Previous studies comparing primary closure with T-tube drainage in open
techniques13 showed a significant reduction in hospital stay and duration of operation with
comparable complication rates. Subsequently, Wu and Soper et al14 , in a prospective
randomised experimental animal study of different laparoscopic techniques of exploration
and closure of the CBD, showed similar reduction in operating time. They also reported that
primary closure of the CBD resulted in a significant increase in stenosis.
OPEN PRIMARY CLOSURE VS T-TUBE DRAINAGE
Ambreen M et al (2009)52 in their study compared the clinical results of primary

closure with T-tube drainage after open choledochotomy and assessed the safety of
primary closure for application on a greater mass. Choledochotomy followed by T-tube has
long been a standard surgical treatment for choledocholithiasis. It is still a preferred choice
in many hospitals where minimal invasive procedures are not feasible. The use of T-tube is
not without complications. To avoid the complications associated with T-tube, they
performed primary closure of the common bile duct after exploration. They assessed the
safety of primary closure of common bile duct. Their comparative study was conducted at
surgical unit IV Liaquat University of Medical and Health Sciences, Jamshoro, from January
23
2007 to December 2007. Thirty-five patients were included in the study of which 16
patients underwent primary closure. The mean age of patients who had primary closure
done (n = 16) was 46.0 ±16.8 and there were two (12.5%) males and 14 (87.5%) females.
After primary closure of the common bile duct, bile leakage was noted in one patient
(6.3%), which subsided without any biliary peritonitis as compared to the T-tube group in
which two patients (10.5%) had bile leakage. Postoperative jaundice was seen in one
patient (5.3%) who had a T-tube because of a blockage of common bile duct. Not a single
patient had a retained stone in both groups as well as no recurrence of common bile duct
stones. The postoperative hospital stay after primary closure was 5.56 ±1.1 days as
compared to after T-tube drainage which was 13.6 ±2.3 days. The total cost of treatment
in patients who underwent primary closure was USD194.5 ±41.5 but after T-tube drainage
it was USD548.6 ±88.5. The median follow up duration for both groups was 6 months. They
concluded that primary common bile duct closure is a safe and cost effective alternative to
routine T-tube drainage after open choledochotomy.
Yamazaki M et al (2006)46 concluded that they preferred primary closure, to get

better quality of life postoperatively and to avoid further operations and any severe
complications. In their study, they evaluated the usefulness of primary closure of the
common bile duct in open laparotomy for common bile duct stones. Thirty-four patients
with common bile duct stones were operated on by open laparotomy; primary closure was
done in 17 patients (group PC), and T-tube insertion was done in 17 (group TT). They
compared the patients' medical records, clinical features, laboratory data, complications,
and postoperative hospital admission days. There were no significant intergroup
differences in patients' medical records, clinical features, or laboratory data, except for the
number of common bile duct stones. There were no differences in complications. All
complications were minor and needed no extra care. The number of postoperative hospital
admission days showed a significant difference: 18.3 days in group PC and 31.5 in group TT.
Sheen-Chen SM et al (1990)6 in their study on thirty patients with stones in the

common bile duct, allocated them alternately to have choledocholithotomy carried out
with either T-tube drainage or with primary closure. Choledochoscopy was done during
24
every operation, and the patency of the common bile duct tested by perfusion. There were
no operative deaths. The length of operation was shorter with primary closure (p-value less
than 0.01) but there were no differences between the groups in operative blood loss, days
in hospital after operation, postoperative morbidity and mortality, and final outcome at
follow up. There was no change in the incidence of postoperative bacteraemia, the number
of adverse reactions, and the incidence of bile peritonitis after removal of the T-tube.
Patients who had T-tubes reported greater discomfort and inconvenience than those
without, and their treatment cost more. They concluded that primary closure of the
common bile duct is a reasonable alternative to T-tube drainage in selected cases.
Xu L et al (2002) 55 in their study investigated the rationality and feasibility of

primary closure of the common bile duct after choledochotomy for common bile duct
calculi. From January 1990 to June 2001, 386 patients with the evidence of stones in the
common bile duct underwent choledochotomy. Among them, 215 received primary closure
of the common bile duct (group A) and 171 T-tube drainage (group B). The patients with
emergency operations were excluded. Intraoperative choledochoscopy or cholangiography
was routinely performed to rule out the possibility of retained stones. The duct was
meticulously stitched using 0/3 to 0/5 absorbent sutures for primary closure. A T-tube was
placed in the sub hepatic space in the patients of both group. Postoperative bile leakage
was seen in 9 patients of group A and in 5 of group B, respectively (p - value > 0.05), and no
reoperations were necessary. After surgery, the average time and volume of transfusion
was 4.9 days and 9.1 litres in group A, versus 7.3 days and 12.8 litres in group B (P < 0.01).
The patients in group B had a longer postoperative hospital stay than the in group A
(average 17.6:10.0 days, p -value < 0.01). T-tube removal resulted in bile peritonitis in 5
patients at day 16, 17, 19, 21 and 22 after surgery in group B, and 3 patients’ required
repeated surgery. They concluded that primary closure of the common bile duct after
choledochotomy is safe, effective, and inexpensive in selected patients with common bile
duct calculi, and should be regarded as an alternative procedure.
Williams JA et al (1994)13 in their study compared primary closure versus T-tube

drainage of the common bile duct following exploration for calculous disease. Thirty-seven
25
patients underwent primary closure and 26 underwent closure over T-tube. Both groups
were comparable in terms of age, indications for surgery, associated illnesses, pre-
operative bilirubin, amylase and white cell count. Forty-three per cent of operations were
performed by a consultant in the primary closure group and 65% in the T-tube group. There
was no significant difference in the duration of operation, incidence of wound infection,
surgical or other complications following operation between the two groups. However, the
postoperative stay was significantly prolonged in the T-tube group, to a median of 11 days,
compared to 8 days in the primary closure group (p value = 0.0001). This prolongation in
stay was unrelated to whether admission was as an emergency or elective. T-tube drainage
of the bile continued for a median of 7 days postoperative, whereas the bile drained via a
wound drain in only 13 (35%) of the primary closure group, for a median of 5 days in these
13 patients. Long-term follow up was achieved in 48 patients, by a questionnaire sent at a
median of 2.8 years following operation. Abdominal pains following recovery from the
operation were experienced by 18% of the primary closure group and 20% of the T-tube
group. No patient developed jaundice or pancreatitis, nor needed further biliary surgery
following operation.
Mokarram Ali MD et al (2016)51 in their study comparing primary closure of

common bile duct with T tube drainage following choledocholithotomy over a period of
one year in 40 patients divided in two groups each of 20 i.e. Group A –primary closure and
Group B -T tube drainage. The results were compared in terms of operating time, duration
of stay at hospital and complications such as leakage and wound infection. It was observed
that primary closure group had less operating time, less duration of hospital stay and less
complication rates as compared to T-tube group. Hence, they concluded that primary
closure can be recommended as safe alternative procedure after choledocholithotomy in
selected patients of choledocholithiasis.
26
LAPAROSCOPIC PRIMARY CLOSURE VS T-TUBE DRAINAGE
Gurusamy KS et al (2013)75 in their review studied whether T-tube drainage may

prevent bile leak from the biliary tract following bile duct exploration and whether it offers
post-operative access to the bile ducts for visualisation and exploration as use of T-tube
drainage after laparoscopic common bile duct exploration is controversial. They assess the
benefits and harms of T-tube drainage versus primary closure after laparoscopic common
bile duct exploration. They searched the Cochrane Central Register of Controlled Trials
(CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index
Expanded until April 2013. They included all randomised clinical trials comparing T-tube
drainage versus primary closure after laparoscopic common bile duct exploration. Two of
four authors independently identified the studies for inclusion and extracted data. They
analysed the data with both the fixed-effect and the random-effects model meta-analyses
using review manager analysis. For each outcome we calculated the risk ratio, rate ratio, or
mean difference with 95% confidence intervals based on intention-to-treat analysis. They
included three trials randomising 295 participants: 147 to T-tube drainage versus 148 to
primary closure. All trials had a high risk of bias. No one died during the follow-up period.
There was no significant difference in the proportion of patients with serious morbidity
(17/147 (weighted percentage 11.3%) in the T-tube drainage versus 9/148 (6.1%) in the
primary closure group; RR 1.86; 95% CI 0.87 to 3.96; three trials), and no significant
difference was found in the serious morbidity rates (weighted serious morbidity rate = 97
events per 1000 patients) in participants randomised to T-tube drainage versus serious
morbidity rate = 61 events per 1000 patients in the primary closure group; RR 1.59; 95% CI
0.66 to 3.83; three trials). Quality of life was not reported in any of the trials. The operating
time was significantly longer in the T-tube drainage group compared with the primary
closure group (MD 21.22 minutes; 95% CI 12.44 minutes to 30.00 minutes; three trials). The
hospital stay was significantly longer in the T-tube drainage group compared with the
primary closure group (MD 3.26 days; 95% CI 2.49 days to 4.04 days; three trials). According
to one trial, the participants randomised to T-tube drainage returned to work
approximately eight days later than the participants randomised to the primary closure
27
group (p - value < 0.005). They concluded that T-tube drainage appears to result in
significantly longer operating time and hospital stay as compared with primary closure
without any evidence of benefit after laparoscopic common bile duct exploration. Based
on their available evidence, there was no justification for the routine use of T-tube drainage
after laparoscopic common bile duct exploration in patients with common bile duct stones.
More randomised trials comparing the effects of T-tube drainage versus primary closure
after laparoscopic common bile duct exploration may be needed and such trials should be
conducted with low risk of bias, assessing the long-term beneficial and harmful effects
including long-term complications such as bile stricture and recurrence of common bile
duct stones.
Huang SM et al (2010) 56 in their study compared the efficacy and safety of

laparoscopic primary closure of the common bile duct combined with percutaneous
transhepatic cholangiographic drainage and laparoscopic choledocholithotomy with T-tube
placement for the treatment of common bile duct stones. Between January 1991 and July
2002, 50 patients with choledocholithiasis and a common bile duct diameter larger than or
equal to 1 cm underwent laparoscopic common bile duct explorations. The study group
consisted of 10 patients undergoing laparoscopic primary closure of the common bile duct
combined with percutaneous transhepatic cholangiographic drainage. The control group
consisted of 40 patients undergoing laparoscopic choledocholithotomy with T-tube
placement. Parameters were compared statistically. The study group showed higher
female/male ratio (6/4 vs. 8/32, p – value = 0.02), less stone numbers (1.90 ± 0.88 vs. 3.40
± 1.65, p – value = 0.0078), shorter operation time (138 ± 37 minutes vs. 191 ± 75 minutes,
p – value = 0.014), and shorter postoperative stays (7 ± 3 days vs. 10 ± 3 days, p – value =
0.0013). They concluded that laparoscopic primary closure of the common bile duct
combined with percutaneous transhepatic cholangiographic drainage can shorten the
operation time and postoperative stays as compared with laparoscopic
choledocholithotomy with T-tube placement for the treatment of common bile duct
stones.
28
Martin IJ et al (1998)47 in their study between August 1991 and February 1997, 300
consecutive unselected patients underwent laparoscopic common bile duct exploration. Of
300 laparoscopic common bile duct exploration procedures, 173 (58%) were managed
using a transcystic approach and 127 (42%) with choledochotomy. Successful laparoscopic
stone clearance was achieved in 271 (90%). Of the 29 (10%) patients not cleared
laparoscopically, 10 had an elective postsurgical endoscopic retrograde cholangiography,
12 were converted to an open procedure early in the series, and 7 had unexpected retained
stones. There was one death (mortality rate 0.3%) and major morbidity occurred in 22
patients (7%). The last 100 procedures were performed from July 1995 to February 1997,
and stone clearance was unsuccessful in only two patients. They concluded that
laparoscopic transcystic basket extraction of common duct stones under fluoroscopic
guidance is a relatively quick, successful, and safe technique. Choledochotomy, when
required, is associated with a higher morbidity rate, particularly with T-tube insertion, and
the authors advocate primary bile duct closure with or without insertion of a biliary stent
as a more satisfactory technique for both surgeon and patient. Most patients with
gallbladder and common duct calculi should expect a curative one-stage laparoscopic
procedure without the need for external biliary drainage or endoscopic retrograde
cholangiography.
Yi HJ et al (2015)57 did their retrospective study on 142 consecutive patients who

underwent laparoscopic common bile duct exploration, combined with choledochoscopy
for common bile duct stones. After laparoscopic common bile duct exploration, the
choledochotomy was closed by primary closure (group P) in 91 patients (64.1%) and with
T-tube drainage (group T) in 51 patients (35.9%). The data on operative outcome and long-
term biliary complications were compared between the 2 groups. RESULTS: The mean
operation time was significantly shorter in group P than group T (168.9 ± 50.1 min for group
P vs. 198.0 ± 59.6 min for group T, p – value = 0.002). The hospital stay was significantly
shorter in group P than in group T (8.59 ± 6.0 d for group P vs. 14.96 ± 5.4 d for group T, p
– value = 0.001). Postoperative bile leak occurred in 2 patients (2.2%) in group P and 1
patient (2.0%) in group T. With a mean follow-up of 48.8 months, the stone recurrence rate
29
in group P and group T were 4.4% and 5.9%, respectively (p – value = 0.722). During the
follow-up period, there was no sign of biliary stricture or other biliary complications in both
groups. They concluded that the long-term follow-up data on primary closure after
laparoscopic common bile duct exploration indicated a low incidence of recurrent stones,
and no biliary strictures. Thus, primary closure after laparoscopic common bile duct
exploration with choledochoscopy is considered to be a safe and effective alternative to T-
tube drainage in terms of long-term outcome.
Yin Z et al (2013)58 compared the efficacy and safety of T-tube free (TTF) versus T-
tube drainage (TTD) after laparoscopic common bile duct exploration. A systematic
literature search (PubMed, EMBASE, Science Citation Index, Springer-Link, and Cochrane
Central Register of Controlled Trials) was performed. Postoperative complications were
evaluated/graded according to the modified Clavien classification. Other variables
extracted including primary closures of the common bile duct and the associated assistant
methods, T-tube types, and placement durations. Stratified and sensitivity analyses were
performed both to explore heterogeneity between studies and to assess the effects of the
study qualities. RESULTS: A total of 956 patients from 12 studies were included. The pooled
odds ratio for postoperative complications and biliary-specific complications in TTF was
found to be 0.59 [95% confidence interval (CI), 0.38-0.91; p – value = 0.02], 0.62 (95% CI,
0.36-1.06; p – value = 0.08), respectively, when compared with TTD. Operative time and
hospital stay were significantly decreased in the TTF group, with the pooled weighted mean
differences being 18.84 minutes (95% CI, -27.01 to 10.67; p – value < 0.01) and 3.22 days
(95% CI, -4.59 to 1.84; p – value < 0.01), respectively. The results of this meta-analysis
demonstrate that among patients undergoing laparoscopic choledochotomy for common
bile duct stones, primary closure of the CBD alone is superior to TTD; however, there is no
significant benefit in terms of primary duct closure with various internal or external
drainage techniques. Further randomized controlled trials are eagerly awaited to prove
these findings.
Zhang HW et al (2014) 59 in their retrospective comparative study aimed to evaluate

on the feasibility and advantages of primary closure versus conventional T-tube drainage
30
of the common bile duct after laparoscopic choledochotomy. In this retrospective analysis,
100 patients (47 men and 53 women) with choledocholithiasis who underwent primary
closure of the CBD (without T-tube drainage) after LCBDE (Group A) were compared with
92 patients who underwent LCBDE with T-tube drainage (Group B). Both groups were
evaluated with regard to biliary complications, hospital stay, and recurrence of stones. The
mean operation time was 104.12 minutes for Group A and 108.92 minutes for Group B (p-
value = 0.069). The hospital stay was significantly shorter in Group A than that in Group B
(6.95 days and 12.05 days, respectively; p – value < 0.001). In Group A, bile leakage occurred
in two patients on postoperative day 2 and day 3, respectively. In Group B, bile leakage
noted in one patient after removal of the T-tube on day 14 after operation (p-value =
1.000). With a median follow-up time of 40 months for both groups, stone recurrence was
noted in two patients in Group A and three patients in Group B (p-value = 0.672). Primary
closure of the CBD is safe and feasible in selected patients after laparoscopic
choledochotomy. It results in shorter duration of hospital stay without the need for
carrying/care of a T-tube in the postoperative period and similar stone recurrence as that
of the conventional method.
Zhang LD et al (2004)60 evaluated the effects of primary duct closure and T-tube
drainage in laparoscopy choledochotomy to treat the common bile duct stones. The
enrollment of the patients was in accordance with 6 criteria. 55 patients with
cholecystolithiasis and secondary common bile duct stones from January 2000 to February
2003 were treated with laparoscopic choledochotomy. The patients were randomly divided
into two groups: primary duct closure group and T-tube drainage group. Their all data were
recorded and studied prospectively, and patients were followed up after discharge.
RESULTS: There were 27 patients and 28 patients in primary duct closure group and T-tube
drainage group respectively. The operation time and the results of following up between
the two groups had no significant difference. Compared with T-tube drainage group,
primary duct closure group had less the total quantity of postoperative transfusion and
hospital costs, shorter postoperative hospital stay. The incidence of postoperative
complications in primary duct closure group was 11.1% (3/27), and all of them were biliary
31
complications. The incidence of postoperative complications in T-tube drainage group was

28.6% (8/28), and seven of them were biliary complications. The incidence of severe
complications that needed reoperations was 10.7% (93/28), and all of them were caused
by T-tubes. There was no mortality in two groups. They concluded that the primary duct
closure in laparoscopic choledochotomy can avoid the deficiency of T-tube drainage, and it
is feasible and safe and lower complications in treating the common bile duct stones, so
we advocate it in appropriate cases.
Zhang WJ et al (2009)61 did their randomized study from May 2000 to January 2008
on 93 consecutive patients with common bile duct stones and gallbladder in situ who
underwent laparoscopic cholecystectomy with laparoscopic common bile duct exploration.
Intraoperative findings, postoperative complications, postoperative stay, and hospital
expenses were recorded and analysed. There was no mortality in both groups. A T-tube
was inserted in 46 patients and the CBD was closed primarily in 47. There were no
differences in the demographic characteristics or clinical presentations between the two
groups. Compared with the T-tube group, the operative time and postoperative stay were
significantly shorter, the hospital expenses were significantly lower, and the incidences of
overall postoperative complications and biliary complications were statistically and
insignificantly lower in the primary closure group. They concluded that LCBDE with primary
closure without external drainage after laparoscopic choledochotomy is feasible and as
safe as T-tube insertion.
Jameel M et al (2008)62 in their study assessed the patient outcome, pre-operative

complications, length of stay and duration of operation after laparoscopic primary closure
of the common bile duct compared with choledochotomy with T-tube drainage and trans-
cystic exploration. Analysis was done on prospectively collected data on 71 explorations of
the common bile duct between July 2001 and March 2006. A total of 71 patients had
exploration of the CBD. Within this group, 12 were referred after failed endoscopic
retrograde cholangiopancreatography. The methods of exploration included trans-cystic (9
cases), choledochotomy with T-tube (12), and choledochotomy with primary closure (50).
CBD stones were found in 66 patients. In the remaining cases, they found a stricture in 1,
32
debris in 2, and dilatation of the CBD without a stone in 2. There were 5 conversions to
open technique and 3 patients required postoperative ERCP (1 with permanent stenting).
Peri-operative complications included T-tube (3), primary closure group (9), and trans-
cystic (0). There was no statistical significant difference (Chi-square test, p – value = 0.296)
between the groups. There was a trend towards a shorter length of stay in the primary
closure group as compared with the trans-cystic and T-tube groups of 4.16, 4.44, and 6.33
days, respectively. However, it did not reach statistical significance (one-way analysis of
variance with boneferroni correction, mean difference between groups 1.89, 0.28, 2,17,
statistical significance at p – value < 0.05). The shortest operating time was in the primary
closure group (95.92 min) which was statistically significant (p – value < 0.001). They did
not use a biliary drain in the last 48 patients. They concluded that primary laparoscopic
closure of the CBD is safe and results in a reduction in operating time. Choledochoscopy
ensures clearance of the CBD and eliminates the need for T-tube.
Croce E et al (1996)7 did their study on Thirty-three patients posted for laparoscopic
choledochotomy. The procedure was completed 32 times (97%). They had 29 successful
common bile duct clearances, three negative explorations, and one failed clearance which
needed to be converted to laparotomy. All the completed procedures ended with primary
closure of the main duct. Median duration of surgery was 180 min (range 100-300),
including three associated laparoscopic procedures. There were three postoperative
complications (9.4%), none major. Average postoperative hospital stay was 7.1 days (range
4-14). In May-June 1995 they controlled 31 out of the 32 consecutive patients (one patient
was lost to follow-up) who had a successful laparoscopic choledochotomy from October
1991 to December 1994. Median follow-up was 22 months (range 5-44). Besides clinical
control, 23 patients also had ultrasound controls and 24 had blood tests. Eleven had
intravenous cholangiotomography. Two patients died 11 and 22 months after the
operation for unrelated causes and without biliary symptoms. Two patients had umbilical
hernias. One had a small residual asymptomatic stone, which was removed endoscopically.
None had signs of postoperative CBD stricture. At ultrasonography, common bile duct was
</=7 mm in 15 patients, 8-10 mm in four patients, and 10-12 mm in three patients. The last
33
group had preoperative common bile duct dilation, too. They could compare preoperative
and postoperative common bile duct diameters in 22 patients: 11 had no change; in nine it
decreased; and two had a slight increase (8-10 mm). They concluded that laparoscopic
choledochotomy with primary closure is a very good operation: It has a high success rate
and low morbidity. Mortality was nil. Medium-term results are very positive: They had no
common bile duct stricture and only one case of asymptomatic residual stone, which could
have been avoided. Their results suggest that intraductal biliary drainage is useless, and its
specific complications are well known.
Decker G et al (2003) 63 reported a prospective multicentric evaluation of

laparoscopic choledochotomy with completion choledochoscopy and primary duct closure
without any biliary drainage. Between October 1991 and December 1997, 100 patients
from four surgical centres underwent this approach for common bile duct stones.
Choledocholithiasis had been demonstrated preoperatively in 35 patients (35%), suspected
in 52 and was incidentally found during routine intraoperative cholangiography in 13
patients. External ultrasound was the only preoperative imaging investigation in 87
patients. Laparoscopic CBD exploration was attempted irrespective of age, ASA score, or
the circumstances leading to the preoperative diagnosis or suspicion of common bile duct
stones (acute cholecystitis in 33% of patients, cholangitis in 10%, or mild acute pancreatitis
in 6% of all patients). The technique was equally feasible in all participating centres
(University hospital, general hospital, or private practices). Vacuity of the CBD was achieved
in all patients without mortality. Eleven patients had complications and 3 patients required
a laparoscopic reintervention. Median postoperative hospital stay was 6 days (range: 1-26).
No patient required additional CBD procedures during follow-up. They concluded that in
case of LCBDE, choledochotomy with primary closure without external drainage of the CBD
is a safe and efficient alternative, even in patients with acute cholecystitis, cholangitis, or
pancreatitis, provided that choledochoscopy visualizes a patent CBD.
Dong ZT et al (2014) 64 assessed the safety and effectiveness of laparoscopic

primary closure for the treatment of common bile duct stones compared with T-tube
drainage. Patients who underwent treatment of common bile duct stones were studied
34
prospectively from 2002-2012 in a single centre. A total of 194 patients were randomly
assigned to group A (LCBDE with primary closure) with 101 cases and group B (LCBDE with
T-tube drainage) with 93 cases. Intraoperative cholangiography and choledochoscopy were
performed in all patients. Patient demographics, intraoperative findings, postoperative
stay, complications, and hospital expenses were recorded and analysed. There was no
mortality in the two groups. Four patients (3.96%) of group A were converted to open
surgery, and three patients (3.23%) in group B. The mean operating time was much shorter
in group A than in group B (102.6 ± 15.2 min versus 128.6 ± 20.4 min, p – value < 0.05). The
length of postoperative hospital stay was longer in group B (4.9 ± 3.2 d) than in group A
(3.2 ± 2.1 d). The hospital expenses were significantly lower in group A. Three patients
experienced postoperative complications, which were related to the usage of the T-tube in
group B. The incidences of overall postoperative complications were insignificantly lower
in group A. They concluded that Laparoscopic primary closure of CBD is safe and effective
for the management of CBD stones, and can be performed routinely as an alternative to T-
tube drainage.
El-Geidie AA et al (2010)65 in their randomized study compared the use of T-tube

and primary closure of choledochotomy after laparoscopic choledochotomy to determine
whether primary closure can be as safe as closure with T-tube drainage. Between February
2006 and June 2009, 122 consecutive patients with proven choledocholithiasis had
laparoscopic choledochotomy. They were randomized into two equal groups: T-tube (n =
61) and primary closure (n = 61). Demographic data, intraoperative findings, postoperative
complications, and postoperative stay were recorded. There was no mortality in both
groups. There were no differences in the demographic characteristics or clinical
presentations between the two groups. Compared with the T-tube group, the operative
time and postoperative stay were significantly shorter and the incidences of overall
postoperative complications and biliary complications were statistically and significantly
lower in the primary closure group. They concluded that laparoscopic common bile duct
exploration with primary closure without external drainage after laparoscopic
35
choledochotomy is feasible, safe, and cost-effective. After verification of ductal clearance,

the CBD could be closed primarily without T-tube insertion.
Ha JP et al (2004)66 did their retrospective analysis on patients who underwent

primary closure of the CBD after successful laparoscopic choledochotomy for ductal stones
between January 2000 and December 2003. A concurrent control group of patients who
underwent T-tube drainage was used for comparison. Of the 64 patients that underwent
laparoscopic exploration of the CBD, 24 (37%) underwent transcystic duct approach and 40
(63%) underwent choledochotomy. There were three open conversions (5%). Stone
clearance was achieved in all patients with successful laparoscopic choledochotomy
(100%). Of the 38 successful laparoscopic choledochotomies, 12 had primary closure of the
CBD and 26 had closure with T-tube drainage. There was no mortality in both groups. One
patient in the primary closure group suffered from paralytic ileus and small subhepatic
collection which was treated conservatively. The median operative time (90 vs. 120
minutes, p – value =0.002) and postoperative stay (5 vs. 8.5 days, p – value =0.003) were
shorter in the primary closure group when compared with the T-tube group. They
concluded that primary closure of the CBD is feasible and as safe as T-tube insertion after
laparoscopic choledochotomy for stone disease.
BILIARY STENT VS T-TUBE FOR BILIARY DECOMPRESSION
Mangla V et al (2012)67 in their study compared the use of a biliary stent with T-
tube for biliary decompression after laparoscopic common bile duct (CBD) exploration.
Between September 2004 and March 2008, 60 patients undergoing laparoscopic CBD
exploration for CBD stones were randomized to choledochotomy closure over either a
biliary stent or a T-tube after CBD clearance. Patients at high risk for surgery and
unremitting cholangitis requiring preoperative endoscopic biliary drainage were excluded.
There were 29 and 31 patients in the T-tube and stenting groups, respectively. The 2 groups
were comparable with respect to their demographic profile and disease characteristics.
Patients in the stent group had a significantly shorter operative time and postoperative stay
with an earlier return to normal activity (p – value <0.0001). They concluded that
choledochotomy closure over a stent results in a shorter postoperative stay and an earlier
36
return to normal activity compared with closure over a T-tube without any increase in
morbidity.
Tang CN et al (2006)68 in their retrospective study compared the use of antegrade

biliary stenting and T-tube drainage following successful laparoscopic choledochotomy.
During the period between January 1995 and July 2003, biliary decompression was
achieved by either antegrade biliary stenting or T-tube drainage based on the discretion of
the operating surgeon. For antegrade biliary stenting, a 10-Fr Cotton-Leung biliary stent
was inserted through the choledochotomy and passed down across the papilla. The stent
position was confirmed by on-table choledochoscopy before interrupted single-layered
closure of the common bile duct. Endoscopic retrograde cholangiopancreatography was
performed to remove the stent 4 weeks after operation and at the same time to check for
any residual stones or other complications like stricture or leak. In the T-tube group, a 16-
Fr latex T-tube was used and the long limb was brought out through the subcostal trocar
port followed by the same method of bile duct closure. Cholangiogram through the T-tube
was performed on day 7 and the tube would be taken off 1 week later (about 2 weeks after
operation) if the cholangiogram did not reveal any abnormality. The two groups were
compared according to the demographic data, operation time, and length of hospital stay
and complication rates. During the study period, 108 laparoscopic explorations of the
common bile duct were performed of which 95 were attempted laparoscopic
choledochotomies and 13 were transcystic duct explorations. Of the 95 patients with
attempted laparoscopic choledochotomy, there were 9 open conversions, 17 laparoscopic
bilioenteric bypasses and 6 primary closures of the common bile duct. All of these patients
together with those receiving transcystic duct explorations were excluded and the
remaining 63 patients having postoperative bile diversion by either antegrade biliary
stenting or T-tube drainage were included in this study. Bile diversion was achieved by
antegrade biliary stenting in 35 patients whereas 28 patients had T-tube drainage. There
was no difference between the two groups in terms of age, clinical presentation, bilirubin
level, length of hospital stay, follow-up duration, common bile duct size, size of common
bile duct stones, incidence of residual/recurrent stone and complication rate. It was
37
observed that more patients in the stenting group developed bile leak (14.2% vs. 3.5%) and
required more intramuscular pethidine injections (182.86 ± 139.30 vs. 92.81±81.15mg, p –
value =0.000). On the other hand, the T-tube group had longer operation time (141.4±45.1
vs. 11 1.1±33.9 minutes, p – value =0.006) and had a longer postoperative hospital stay
(10.0±7.4 vs. 8.8±9.3 days, p – value =0.020) reaching statistical significance. They
concluded that postoperative bile diversion by antegrade biliary stenting after laparoscopic
choledochotomy is shown to shorten operation duration and postoperative stay as
compared to T-tube drainage, but the problem of bile leak needs further refinement of
insertion technique.
Perez G et al (2005)4 in their prospective randomized study compared clinical results

obtained from patients who underwent open CBD exploration using a biliary stent versus
those from patients with a T-tube for decompression. Between September 2000 and June
2002 a total of 81 patients were randomly assigned to a biliary stent or a T-tube as the
decompression method following choledochotomy. An open CBD exploration was
performed when CBD stones were suspected, in both elective and emergency settings. The
length of the postoperative hospital stay was 6.8 ± 4.7 days for patients with the T-tube
and of 5.2 ± 3.3 days for, patients with the biliary stent (p – value = 0.19). Postoperative
complications were observed in 13 patients (30%) with the T-tube and in 4 patients (11%)
with the biliary stent (p – value = 0.03). One patient with a biliary stent was re-operated
because of an intra-abdominal abscess, and another patient was re-operated because of
biliary peritonitis following T-tube removal. Three patients (7%) with a biliary stent and one
patient (3%) with a T-tube were re-hospitalized. There were no deaths. The T-tube and
biliary stent were removed 27.1 ± 10.8 days and 34.9 ± 12.9 days after surgery, respectively
(p – value = 0.24). They concluded that biliary stent is a safe alternative to the T-tube as a
biliary decompression method following an open CBD exploration.
Dietrich A et al (2014) 69 in their study between January 2007 and May 2012
retrospectively analysed 48 patients who underwent biliary decompression after
laparoscopic common bile duct exploration to treat choledocholithiasis. The results in
patients with transpapillary stent placement (TS=35) were compared with those who had
38
an external biliary drainage (EBD=13). LCBDE and TS placement was achieved either by a
choledochotomy or through the cystic duct. No mortality was reported. Patients with an
external biliary drainage had more surgery-related complications (p – value <.0001) and a
longer hospital stay (p – value =.03). Postoperative ERCP to remove transpapillary stent was
successful in all cases. They concluded that laparoscopic transpapillary stent is a safe
method in the treatment of selected patients with CBD stones that can be achieved without
having to perform a choledochotomy. Because of the lower morbidity and the shorter
hospital stay compared with EBD, it should be considered as a first approach whenever
biliary decompression is needed after LCBDE.
39
BILIARY LEAKAGE AFTER PRIMARY CLOSURE AND T-TUBE DRAINAGE
Hua J et al (2015)70 in their study examined the efficacy and safety of primary duct
closure following laparoscopic common bile duct exploration via choledochotomy.
Between September 2011 and September 2013, 157 consecutive patients underwent
LCBDE via choledochotomy. Of 157 LCBDE procedures, 138 (87.9%) were successfully
completed with primary closure of the choledochotomy. Eight patients (5.1%) underwent
closure with T-tube drainage after choledochotomy and 11 patients (7.0%) were converted
to open surgery. The biliary tree was free of stones at the end of surgery in 154 patients
(98.1%). Postoperative bile leak occurred in 6 patients (3.8%). The median follow-up period
was 18 (2-33) months, with no evidence of further bile duct stones or bile duct stricture in
any patients. Univariable analysis revealed that successful duct clearance (p – value =
0.010) and diameter of the common bile duct (p – value < 0.001) were two significant risk
factors for bile leak. They concluded that primary duct closure following LCBDE is effective
and safe for the management of choledocholithiasis. The postoperative bile leak rate may
be low in skilled laparoscopic surgeons with a careful selection of patients.
Wills VL et al (2002)11 in their study reviewed the complications associated with T-

tube drainage and assessed whether laparoscopic procedures are associated with an
increase in complications relating to T-tube use. Case records from two large public
hospitals in New South Wales (Australia) were analysed retrospectively for a 10-year period
using a standardized data collection form. Morbidity, mortality and potential factors
influencing the complication rate after choledochotomy and T-tube insertion were
recorded. All complications were reviewed by an experienced biliary surgeon. T-tubes were
inserted in 274 patients, with 42 patients (15.3%) experiencing a total of 60 complications
relating to T-tube use. Morbidity occurring while the tube was in situ included fluid and
electrolyte disturbance (five patients), sepsis (ten patients), premature dislodgement
(three patients) and bile leakage (six patients). Complications resulting after planned tube
removal included localized pain (thirteen patients), biliary peritonitis (seven patients), a
prolonged biliary fistula (seven patients) and a late bile duct stricture (one patient). T-tube
complications resulted in a prolonged hospital stay (19 days vs 13 days, p – value = 0.005),
10 additional abdominal operations and two deaths. Complications related to T-tubes were
constant over the study period and were similar between laparoscopic and open cases
(13.8% vs 15.5%, p – value = 0.81). Although this retrospective review is likely to have
underestimated the incidence of T-tube complications, it has demonstrated significant
morbidity associated with T-tube use. The incidence of these complications has been
constant and is unrelated to a laparoscopic approach.
Gharaibeh KI et al (2000)10 in their study evaluated the incidence of biliary leakage

following T-tube removal from the common bile duct ( in 97 patients who underwent open
CBD exploration. In 93 patients, this was following exploration for CBD stones, in two
patient it was for obstructive jaundice due to hydatid disease and in a further two patients
it was following CBD injury. T-tube cholangiography (TTC) was carried out 7-10 days
postoperatively and, if the examination was normal, the T-tube was removed 12-14 days
postoperatively (2 months for the CBD injury patients). Following T-tube removal, six
patients developed severe abdominal pain, sweating and tachycardia. They were treated
with antibiotics, parenteral fluids, and analgesia. Three patients settled with this
management. Two patients developed sub-hepatic collections and required open drainage.
One patient developed a small pelvic collection, which was aspirated transvaginally. A
seventh patient was re-admitted 2 weeks following T-tube removal and laparotomy
revealed biliary peritonitis. The patient died the following day. They concluded that biliary
leakage following removal of a T-tube is not uncommon. It has a significant morbidity and
mortality.
SURGICAL VERSUS ENDOSCOPIC MANAGEMENT
Dasari BV et al (2013)48 in their systematic review analysed the benefits and harms
of different approaches to the management of common bile duct stones. They searched
the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of
Controlled Trials (CENTRAL, Issue 7 of 12, 2013) in The Cochrane Library, MEDLINE (1946 to
August 2013), EMBASE (1974 to August 2013), and Science Citation Index Expanded (1900
to August 2013). They included all randomised clinical trials which compared the results
from open surgery versus endoscopic clearance and laparoscopic surgery versus
endoscopic clearance for common bile duct stones. Two review authors independently
identified the trials for inclusion and independently extracted data. They calculated the
41
odds ratio or mean difference with 95% confidence interval using both fixed-effect and
random-effects models meta-analyses, performed with review manager. Sixteen
randomised clinical trials with a total of 1758 randomised participants fulfilled the inclusion
criteria of this review. Eight trials with 737 participants compared open surgical clearance
with ERCP; five trials with 621 participants compared laparoscopic clearance with pre-
operative ERCP; and two trials with 166 participants compared laparoscopic clearance with
postoperative ERCP. One trial with 234 participants compared LCBDE with intra-operative
ERCP. There were no trials of open or LCBDE versus ERCP in people without an intact
gallbladder. All trials had a high risk of bias. There was no significant difference in the
mortality between open surgery versus ERCP clearance (eight trials; 733 participants; 5/371
(1%) versus 10/358 (3%) OR 0.51; 95% CI 0.18 to 1.44). Neither was there a significant
difference in the morbidity between open surgery versus ERCP clearance (eight trials; 733
participants; 76/371 (20%) versus 67/358 (19%) OR 1.12; 95% CI 0.77 to 1.62). Participants
in the open surgery group had significantly fewer retained stones compared with the ERCP
group (seven trials; 609 participants; 20/313 (6%) versus 47/296 (16%) OR 0.36; 95% CI 0.21
to 0.62), p – value 0.0002.There was no significant difference in the mortality between LC
+ LCBDE versus pre-operative ERCP +LC (five trials; 580 participants; 2/285 (0.7%) versus
3/295 (1%) OR 0.72; 95% CI 0.12 to 4.33). Neither was there was a significant difference in
the morbidity between the two groups (five trials; 580 participants; 44/285 (15%) versus
37/295 (13%) OR 1.28; 95% CI 0.80 to 2.05). There was no significant difference between
the two groups in the number of participants with retained stones (five trials; 580
participants; 24/285 (8%) versus 31/295 (11%) OR 0.79; 95% CI 0.45 to 1.39).There was only
one trial assessing LC + LCBDE versus LC+intra-operative ERCP including 234 participants.
No mortality reported in either of the groups. There was no significant difference in the
morbidity, retained stones, procedure failure rates between the two intervention groups.
Two trials assessed LC + LCBDE versus LC+post-operative ERCP. There was no reported
mortality in either of the groups. There was no significant difference in the morbidity
between laparoscopic surgery and postoperative ERCP groups (two trials; 166 participants;
13/81 (16%) versus 12/85 (14%) OR 1.16; 95% CI 0.50 to 2.72). There was a significant
difference in the retained stones between laparoscopic surgery and postoperative ERCP
42
groups (two trials; 166 participants; 7/81 (9%) versus 21/85 (25%) OR 0.28; 95% CI 0.11 to
0.72; p – value = 0.008.In total, seven trials including 746 participants compared single
staged LC + LCBDE versus two-staged pre-operative ERCP + LC or LC + post-operative ERCP.
There was no significant difference in the mortality between single and two-stage
management (seven trials; 746 participants; 2/366 versus 3/380 OR 0.72; 95% CI 0.12 to
4.33). There was no a significant difference in the morbidity (seven trials; 746 participants;
57/366 (16%) versus 49/380 (13%) OR 1.25; 95% CI 0.83 to 1.89). There were significantly
fewer retained stones in the single-stage group (31/366 participants; 8%) compared with
the two-stage group (52/380 participants; 14%), but the difference was not statistically
significant OR 0.59; 95% CI 0.37 to 0.94).There was no significant difference in the
conversion rates of LCBDE to open surgery when compared with pre-operative, intra-
operative, and postoperative ERCP groups. Meta-analysis of the outcomes duration of
hospital stay, quality of life, and cost of the procedures could not be performed due to lack
of data. They concluded that open bile duct surgery seems superior to ERCP in achieving
common bile duct stone clearance based on the evidence available from the early
endoscopy era. There is no significant difference in the mortality and morbidity between
laparoscopic bile duct clearance and the endoscopic options. There is no significant
reduction in the number of retained stones and failure rates in the laparoscopy groups
compared with the pre-operative and intra-operative ERCP groups. There is no significant
difference in the mortality, morbidity, retained stones, and failure rates between the
single-stage laparoscopic bile duct clearance and two-stage endoscopic management.
More randomised clinical trials without risks of systematic and random errors are necessary
to confirm these findings.
43
PATIENTS AND METHOD
44
Patients and methods
Study Design
This study was designed as a prospective interventional study with an aim of
including all symptomatic patients, who fulfil the selection criteria for the study population
and visit hospital during study period. The patients, diagnosed as choledocholithiasis and
subsequently undergoing choledocholithotomy in this setting were regarded as index
cases. Thirty two such patients were included in the study. The same group of patients was
studied before and after choledocholithotomy. The study was conducted on patients
operated between January 2017 and April 2018 (16 months).
Due approval of the hospital ethics committee was obtained before commencing
the study.
Material
A. PATIENT SELECTION
1. Study population
Cases of jaundice who attended in the department of surgery OPD, central referral
hospital, a 500 bedded hospital, associated to Sikkim Manipal Institute of Medical Sciences,
Gangtok , were evaluated clinically and sonologically for common bile duct stones and were
included in the study.
2. Sample size
Sample size was calculated assuming the mean operation time in primary closure
group 1 as 100.6 minutes and in T-Tube group as 125.1 minutes with respected standard
deviations of 20 and 25 respectively, as per previous study by El-Geidie, A. A. et al65. The
other parameters considered for sample size calculation were 80% power of study and 5%
alpha error. The following formula was used for sample size calculation. 71
(u + v)2 (σ12 + σ20 )

N=
(μ1 − μ0 )2
N = Sample size
µ1 – µ0 = Difference between the means ( 100.6 and 125.1)
σ1, σ0 = Standard deviations (20 and 25)
U = one-sided percentage point of the normal distribution corresponding to ‘100 % –
the power’. If the power is = 80%, u =0.84
V = Percentage point of the normal distribution corresponding to the (two-sided)
significance level e.g. If significance level = 5%, v = 1.96
45
As per the above mentioned formula, the required number of subjects in each of
the study groups is a minimum of 14 subjects. To account for a non-participation rate of
10% another 2 subjects will be added to each group. Hence the final required sample size
would be 16 subjects.
3. Consent of participants
Once selected for the study, the patients’ written consent was sought after full
explanation of the procedure and the commitment for follow-up visit.
Those who refused, or were not willing to give their consent, were excluded from
the study at this point itself.
4. Selection criteria
a. Inclusion criteria:
Patients with jaundice having cholelithiasis and common bile duct stones (proven
pre-operatively) OR having common bile duct stones only.
b. Exclusion criteria:
 Grossly thickened bile-duct wall / recent cholangitis
 Equipment or other technical failure leading to ergonomic difficulties
 Any deviation of standard surgical protocol for choledocholithotomy
 Presence of intra-hepatic stones
 Biliary strictures
 Choledocholithiasis with pregnancy
 Suspicion of malignancy at presentation
 Older than 80 years old, patients with history of laparotomy, history of heart failure,
renal failure, cerebrovascular accidents and myocardial infarction
Method
B. STANDARD PROCEDURAL METHOD
 All enrolled patients were given prophylactic antibiotics (Injection cefaperzone 1

gram IV half hour prior to induction of anaesthesia).
46
 Biliary tree was approached via a right sub-costal incision.
 Calot’s triangle was dissected to skeletonize cystic artery and duct.
 CBD was confirmed by aspiration of bile.
 A longitudinal supraduodenal choledochotomy was done between stay sutures
placed on CBD.
 Stones were retrieved with Desjardin forceps, or were milked out, and common bile
duct were be irrigated with normal Saline. Proximal and distal patency were
checked in all cases.
 Rigid ureteroscope were used to check for complete clearance and patency of both
proximal and distal bile duct.
 Confirmation of patency of common bile duct was done by intraoperative
cholangiogram.
 Patients with CBD diameter more than 15 mm were included in the primary closure
group. The choledochotomy was closed primarily with interrupted 4-0 absorbable
sutures (4-0 polydioxanone). At the end of the procedure, a single 30F sub-hepatic
drain were placed.
 Those with CBD diameter less than 15 mm were included in the T-tube drainage
group. A silicone t-tube of appropriate size (14-16 French size) were inserted into
the common bile duct and common bile duct incision were closed using interrupted
sutures (4-0 polydioxanone). Saline was flushed through the T-tube to rule out
leakage. At the end of the procedure, a single 30F sub-hepatic drain were placed.
 Cholecystectomy was performed after ligation and division of cystic duct and artery.
 Closure of abdominal wall was done in 2 layers using polyglactin 2-0 sutures. Drain
/ T-tube were secure in situ with silk 1-0.
 The day after the surgery, patients were ambulated and returned to oral intake as
tolerated.
 Post-operative parameters, as detailed below, were recorded.
 T-tube cholangiogram was performed on 10th – 12th post-operative day prior to

removal; and sub-hepatic drain was removed on the next day in the T-tube group.
C. STUDY PARAMETERS
This prospective, interventional study were conducted at the department of surgery,

central referral hospital, gangtok.
47
Clinical record of all the patient will be taken down for a period of January 2017 to April
2018 with following details:
1. Pre-operative symptoms
a) Biliary colic
b) Acute cholecystitis
c) Jaundice
d) Fever
e) Altered sensorium
2. Pre-operative parameters
a) Age
b) Gender
c) Co-morbidities:
i. Hypertension
ii. Diabetes mellitus
d) Body mass index (height and weight will be taken to calculate BMI)
e) Sonographic and MRCP assessment:
i. Common bile duct diameter (mm)
ii. Number of common bile duct stones
iii. Concomitant gall-bladder stones
3. Intra operative parameters
a) Total Duration of surgery (minutes)

b) Common bile duct clearance method = sounding/flushing , cholangioscopy
c) Confirmation of patency: Intra-operative cholangiogram
d) Common bile duct closure method : Primary closure / T-tube drainage
4. Post-operative parameters
a) Post-operative complains : nausea/vomiting , pain based on visual

analogue scale were recorded in each group
b) Post-operative Day 3 total bilirubin, direct bilirubin and alkaline phosphate
values were recorded.
c) Daily drain out in primary closure group and drain output including T –tube
bile output were in T- tube group
48
d) In the T-tube group, T-tube cholangiogram were performed on the 9-12th
postoperative day and tube was removed after confirmation of free flow of
contrast with no residual stone.
e) If there was an insignificant output from drain, it was removed and
patients were discharged.
f) Hospital stay defined as postoperative admission days were recorded in
each group.
g) Postoperative complications : bile leakage, acute pancreatitis, acute biliary
peritonitis after t-tube removal , acute biliary peritonitis after drain
removal , wound cellulitis and hospital expenses (Rupees) were recorded
for each group.
D. STATISTICAL METHODS
The data collected were tabulated and analysed by SPSS (statistical package for
social sciences) software version 21.0 for windows as well as Microsoft excel 2016 with
inbuilt statistical analysis tool. Different statistical aggregates like mean, median and mode
were used to analyse numerical (scale) variables. Frequency distribution were used in case
of non-numerical variables (nominal and ordinal) variables. Attempts were made to
graphically represent the results as far as possible. Appropriate statistical methods were
used to determine the significance of differences between various comparisons.
a. Student’s t-test: For difference between means of different data arrays paired or unpaired
two-tailed Student’s t-test was employed, depending on the circumstance.
b. Chi-square (χ²) test: Chi-square (χ²) test was used for evaluation of the significance of
difference in distribution of different data arrays.
c. Mann-Whitney U-test: U- test was used for evaluation of the significance of difference in
means and medians of a given parameter between the two groups.
Irrespective of the method used, differences between various parameters among different
groups or subgroups were considered significant if the p value was less than 0.05. If p value was >
0.05 then the differences were considered statistically insignificant.
49
OBSERVATIONS
Observations
This study was conducted in the department of General Surgery, Central Referral
Hospital and Sikkim Manipal Institute of Medical Sciences, Gangtok- a 500 bedded teaching
hospital. It caters to the population in Sikkim, where the population according to 2011
census was 610,577.
Presuming a prevalence rate of 10% the number of individuals with gall-stones

could be around 60000. For the last several years about 300-500 cholecystectomies and
30-50 choledocholithotomies are being performed annually in Central Referral Hospital and
Sikkim Manipal Institute of Medical Sciences, Gangtok.
During the study period of 16 months, from January 2017 to April 2018, 835
cholecystectomies and 50 choledocholithotomies were performed in the study institution.
This group was designated the ‘population group’ for the current study. From this
‘population group’, 32 patients who fulfilled the selection criteria (on page 46) were
selected.
Demographics
A. SEX
In primary closure group 2 (12.5%) were male, and remaining 14 (87.5%) were
female. In T-tube group 10 (62.5%) were male, and remaining 6 (37.5%) were female. The
difference in the proportion of gender between groups was statistically significant (p value
0.003) (Table 1 & figure 2).
B. AGE
The mean age was 40.81 ± 15.08 in primary closure group and it was 47.5 ± 11.66
in T-tube, the difference between two groups was statistically not significant (p value
0.171). (Table 1 & figure 1).
C. BODY-MASS INDEX
The mean BMI was 25.93 ± 2.51 in primary closure group and it was 27.68 ± 2.68 in
T-tube, the difference between two groups was statistically not significant (p value 0.065).
(Table 1 & figure 3).
51
Observations
Table 1: Comparison of demographic parameter between the two study groups (N=32)
Group
Demographic p- Test
Parameter Primary Closure T- tube value applied
Age (Mean ±SD) 40.81 ± 15.08 47.5 ± 11.66 0.171
Gender
Male (%) 2 (12.5%) 10 (62.5%)
0.003
Female (%) 14 (87.5%) 6 (37.5%)
Height cm (Mean
163.31 ± 2.98 164.56 ± 2.22 0.189
±SD)
Weight kg (Mean
69.16 ± 7.27 74.94 ± 7.95 0.040
±SD)
BMI (Mean ±SD) 25.93 ± 2.51 27.68 ± 2.68 0.065
Figure 4: Bar chart of comparison of age between the two study groups (N=32)
50
47.5
48
46
Age (Mean)
44
42 40.81
40
38
36
Primary Closure T- tube
Figure 5: Stacked bar chart comparing of gender distribution between the two study
groups (n=32)
100%
80% 37.5
Percentage
60% 62.5
40% 87.5
20%
12.5
0%
Male Female
Primary closure T- tube
Figure 6: Bar chart of comparison of BMI between the two study groups (N=32)
28 27.68
27.5
BMI (Mean)
27
26.5
25.93
26
25.5
25
52
Observations
Pre-operative parameters
A. CLINICAL PRESENTATION
In primary closure group 9 patients (56.3%) presented with biliary colic. In T-tube
group 12 patients (75%) presented with biliary colic. The difference in the proportion of
biliary colic between groups was statistically not significant (p value 0.264). In primary
closure group 5 patients (31.3%) presented with acute cholecystitis. In T-tube group 2
patients (12.5%) presented with acute cholecystitis. The difference in the proportion of
acute cholecystitis between groups was statistically not significant (p value 0.200). In
primary closure group 11 patients (84.6%) had jaundice. In T-tube group 12 (92.3%) had
jaundice. The difference in the proportion of jaundice between groups was statistically not
significant (p value 0.539) (Table 2).
Table 2: Comparison of group with clinical presentation of study population (N=32)

Group
Parameter
Primary Closure (N=16) T- tube (N=16) Chi square p-value
Biliary colic
Yes 9 (56.3%) 12 (75%)
1.247 0.264
No 7 (43.8%) 4 (25%)
Acute cholecystitis
Yes 5 (31.3%) 2 (12.5%)
1.646 0.200
No 11 (68.8%) 14 (87.5%)
Jaundice
Yes 11 (84.6%) 12 (92.3%)
0.377 0.539
No 2 (15.4%) 1 (7.7%)
B. CO-MORBIDITIES
In primary closure group 3 patients (18.7%) had diabetes mellitus. In T-tube group
4 patients (25%) had diabetes mellitus. The difference in the proportion of incidence of
diabetes mellitus between groups was statistically not significant (p-value= 0.411).
In primary closure group 4 patients (25%) had hypertension. In T-tube group 8

patients (50%) had hypertension. The difference in the proportion of incidence of
hypertension between groups was statistically not significant (p-value= 0.144) (Table 3).
53
Observations
Table 3: Comparison of group with Co-morbidities of study population (N=32)

Co-morbidities Group Chi square P-value
Diabetes mellitus
Yes 3 (18.7%) 4 (25%)
0.675 0.411
No 13 (81.3%) 12 (75%)
Hypertension
Yes 4 (25%) 8 (50%)
2.133 0.144
No 12 (75%) (50%)
C. PRE-OPERATIVE LABORATORY VALUES
a) Preoperative haematological parameters

The mean pre-operative haemoglobin was 13.76 ± 1.66 g/dl in primary closure
group and it was 14.36 ± 1.5 g/dl in T-tube, the difference between two groups was
statistically insignificant (p-value= 0.220). The mean pre-operative total leucocyte count
was 8093.75 ± 2189.21 in primary closure group and it was 7918.75 ± 2137.98 in T-tube,
the difference between two groups was statistically insignificant (p-value= 0.821)
(Table 4 & Figure 4, 5).
Table 4: Comparison of pre-operative haematological parameters between the two study

groups (N=32)
Group Independent
Primary Closure T- tube sample test
Parameter
(Mean ±SD) (Mean ±SD) P- value
Pre-operative haemoglobin (g/dl) 13.76 ± 1.66 14.36 ± 1.5 0.279
Pre-operative total leucocyte Count 8093.75 ± 2189.21 7918.75 ± 2137.98 0.802
Figures 7 and 8: Comparison of pre-operative haemoglobin and TLC between the two
study groups (N=32)
14.6
14.36 8150
Pre op total leucocyte count
14.4 8093.75
Pre ope haemoglobin (mean)
8100
14.2
8050
14
(Mean)
8000
13.8 13.66 7950 7918.75
13.6 7900
13.4 7850
13.2 7800
Primary Closure T- tube Primary Closure T- tube
54
Observations
b) Pre-operative liver function test

The mean total bilirubin of 6.23 mg/dl in the primary closure group and 4.79 mg/dl
in T-tube group was statistically insignificant (p-value= 0.303) (Table 5 & Figure 6 ).
Similarly the difference between mean direct bilirubin between primary closure and
T-tube groups (3.54mg/dl and 3.11mg/dl respectively) was statistically insignificant (p-
value= 0.561) (Table 5 & Figure 7).
Also, the observed difference in the mean alkaline phosphatase, was statistically in
significant (p-value= 0.168). It was 341.24U/L in the primary closure group, and 277.63U/L
in the T-tube group (Table 5 & Figure 8).
Table 5: Comparison of mean value of pre-operative liver function parameter between

the two groups (N=32)
Group Independent
Parameter sample test
P- value
(Mean) (Mean)
Pre-operative total bilirubin (mg/dl ) 6.23 4.79 0.303
Pre-operative direct bilirubin (mg/dl) 3.54 3.11 0.561
Pre-operative alkaline phosphatase (U/L) 341.24 277.63 0.168
Figure 9, 10 & 11: Comparison of mean values of LFTs between the two groups (N=32)
6.4 3.6
3.54 400
6.3
Pre-operative alkaline phosphate (Mean)
6.3
3.5 341
350
Pre-operative direct bilirubin (Mean)
Pre-operative total bilirubin (Mean)
6.2
3.4
300 277
6.1
3.3
6 250
5.9 3.2 200

3.11
5.8
5.71 3.1 150
5.7
3 100
5.6
2.9 50
5.5
5.4 2.8 0
Primary T- tube Primary T- tube Primary T- tube
closure closure closure
55
Observations
D. IMAGING STUDIES
a) Sonological findings
The mean sonologically determined mean common bile duct diameter in the
primary closure group was 17.71mm while it was 13.58mm in patients in the T-tube group.
This difference in the common bile duct diameter based on USG between groups was
statistically significant (p-value <0.001).
In primary closure group 14 (87.5%) patients had concomitant gall-bladder stones

on while in the T-tube group 15 (93.8%) patients had concomitant cholelithiasis. This
difference was statistically insignificant (chi-square p-value = 0.544). (Table 6 & Figure 9 )
Table 6: Comparison of mean value in group between USG finding (N=32)

Group
USG finding Primary Closure T- tube P value
Mean common bile duct diameter (mm) 17.71 13.58 <0.001
Number of common bile duct stones USG
Multiple 8 (50%) 14 (87.5%)
Solitary 8 (50%) 0 (0%) *
No stone 0 (0%) 2 (12.5%)
Concomitant gall-bladder stones USG
Present 14 (87.5%) 15 (93.8%)
0.544
Absent 2 (12.5%) 1 (6.3%)
*No statistical test was applied- due to 0 subjects in the cells.
Figure 12 : Pie chart of comparison of mean common bile duct diameter (mm) on USG
13.58 Primary closure

T- tube
17.71
56
Observations
b) MRCP findings
Of the 32 enrolled patients, USG failed to confirm presence or number of stones
within the CBD in 10 patients. These patients were therefore subjected to MRCP. In the
primary closure group MRCP detected multiple common bile duct stones in 3 (18.8%)
patients and solitary common bile duct calculus in another 3 (18.8%) patients. In the T-tube
group MRCP detected multiple common ducts stones in 3 (18.8%) patients and solitary
common duct calculus in another 1 (6.3%) patient. The difference in the proportion of
number of common bile duct stones reported MRCP between groups was statistically not
significant (chi-square p-value= 0.554).
The mean common bile duct diameter reported on MRCP was 17.36mm in primary
closure group and it was 13.25mm in T-tube, similar to the USG measurements. The
difference between two groups was statistically significant (chi-square p-value= 0.017)
(Table 7 & figure 10).
Table 7: Comparison of group with MRCP finding of study population (N=32)

Group
P-value
MRCP finding Primary Closure T- tube
(N=16) (N=16)
Number of common bile duct stones MRI
Multiple 3 (18.8%) 3 (18.8%)
Solitary 3 (18.8%) 1 (6.3%) 0.554
Not done 10 (62.5%) 12 (75%)
Men common bile duct diameter MRCP (mm) 17.36 13.25 0.016
Figure 13 : Pie chart of comparison of mean common bile duct diameter (mm) on MRCP
13.25
Primary closure
17.36 T- tube
57
Observations
Intra-operative parameters
The mean total duration of the surgery was 132.44 minutes ± 10.06 in the primary
closure group and it was 146.31 minutes ± 5.62 in the T-tube group. The difference
between two groups was statistically significant (p-value <0.001) (Table 8 & Figure 11).
Table 8: Comparison of total duration of the surgery (minutes) between the two study
groups (N=32)
Group Independent sample T-
test p-value
Primary
Parameter
Closure T- tube
(Mean ±SD) (Mean ±SD)
Total duration of the
132.44 ± 10.06 146.31 ± 5.62 <0.001
surgery (minutes)
Figure 14 : Bar chart of comparison of total duration of the surgery (minutes) between
the two study groups (N=32)
150
146.31
Total duration of the surgery - minutes
145
140
(Mean)
135
132.44
130
125
58
Observations
Post-operative parameters
A. POST –OPERATIVE LABORATORY VALUE
The mean total bilirubin 72 hours after surgery was 1.09 mg/dl in primary closure
group while it was 1.02 mg/dl in the T-tube, the difference between the two groups being
statistically insignificant (p-value= 0.743) (Table 9 & Figure 12).
Table 9: Comparison of total and direct bilirubin 72 hours post-operatively between the
two study groups (N=32)
Group Independent
Primary Closure T- tube sample test
Parameter
(Mean ) (Mean ) p-value
Total bilirubin 72 hr post - operative 1.09 1.02 0.742
Direct bilirubin 72 hr post - operative 0.43 0.33 0.319
Figure 15 and 16 : Bar chart of comparison of post - operative total bilirubin 72 hr

1.1 0.5
1.09
0.43
Post operative direct bilirubin 72 hours (Mean)
0.45
Post operative total bilirubin 72 hours (Mean)
1.08
0.4
0.35 0.33
1.06
0.3
1.04 0.25
0.2
1.02
1.02
0.15
0.1
1
0.05
0.98 0
Primary closure T- tube Primary closure T- tube
Similar to the total bilirubin assay values, the difference in mean direct bilirubin
between the two groups 72 hours post-operatively was statistically insignificant (p-value
0.319), being 0.43 mg/dl in the primary closure group, and 0.33 mg/dl in the T-tube group
(Table 10 & Figure 13).
59
Observations
Among the patients in the primary closure group, the mean post-operative alkaline
phosphatase was 59.41 U/L and it was 93.06 U/L in the T-tube group. This difference in the
post-operative alkaline phosphatase between groups was statistically significant (p-value
0.027) (Table 11 & Figure 14).
Table 10: Comparison of value of alkaline phosphatase between the two groups 72
hours post-operatively (N=32)
Group Independent
Parameter sample test
P- value
Mean Mean
72 hr post-operative
59.41 93.06 0.027
alkaline phosphatase
Figure 17 : Bar chart of comparison of mean value of post-operative alkaline

phosphatase between the two groups (N=32)
100
93.06
Post operative alkaline phosphate 72 hours
90
80
70
59.41
60
(Mean)
50
40
30
20
10
0
B. DAILY SUB HEPATIC DRAIN OUTPUT
The mean sub-hepatic drain output on 1st post-operative day was 139ml in primary
closure group while in T-tube group it was 124ml. Over the course of patient stay in
hospital, it progressively decreased to 19ml in primary closure group and 16ml in T-tube
group on 9th post-operative day. Details are detailed in table 12 and depicted graphically
in figure 15. The differences in mean output between the two groups were statically
insignificant in each group.
60
Observations
Table 11: Comparison of drain output (ml) between the two study groups (N=32)
Group Independent sample t-test
Drain output Primary Closure T- tube p-value
Day 1 (Mean) 139 124 0.27
Day 2 (Mean) 113 108 0.68
Day 3 (Mean) 91 85 0.63
Day 4 (Mean) 74 74 0.95
Day 5 (Mean) 50 63 0.02
Day 6 (Mean) 40 51 0.04
Day 7 (Mean) 28 37 0.02
Day 8 (Mean) 23 25 0.70
Day 9 (Mean) 19 16 0.47
FIGURE 18 : TREND LINE DIAGRAM OF COMPARISON OF DRAIN OUTPUT BETWEEN THE TWO GROUPS
(N=32)
160
140
120
Sub-hepatic darin output
100
(Mean)
80
Primary closure
60 T- tube
40
20
0
0 2 4 6 8 10
Day
C. TIME TO DRAIN REMOVAL
The sub-hepatic drain was removed on the 9th day at average in the primary closure
group, while in the T-tube group it was removed on the 12th day on average. This difference
was statically significant (p-value <0.001) (Table 13 & Figure 16). The delay in the T-tube
group was because the check cholangiogram prior to drain removal was done after the 10th
day, and drain was removed only after that confirmation.
61
Observations
Table 12: Comparison of time to drain removal between the two groups (N=32)
Group
Day of drain
removal Primary Closure T- tube
Independent sample t-test

Mean ± SD 8.12 ± 0.21 11.56 ± 0.20
p-value <0.001
Mann Whitney U test
Median (IQR) 9 (7 to 11) 12 (11 to 13)
p-value <0.001
Figure 19 : Comparison of the mean ‘time to drain removal’ (days) between the two study
groups (N=32)
14
12 11.56
Time to remove drain (days) -mean
10
8.12
8
0
D. POST-OPERATIVE COMPLAINS
a) Nausea / Vomiting
In primary closure group 7 (43.8%) patients and in the T-tube group 8 (50%) patients
had post-operative nausea or vomiting (p-value= 0.723) (Table 14).
Table 13: Comparison of group with post-operative nausea vomiting (N=32)

Group
Post-operative Chi square P-value
nausea vomiting
(N=16) (N=16)
Yes 7 (43.8%) 8 (50%)
0.125 0.723
No 9 (56.3%) 8 (50%)
62
Observations
b) Pain (visual analog scale)

Among the patients with primary closure group, the median pain 6 hours post-
operatively based on visual analog scale was 6 (IQR 5 to 6) and it was 5.50 (IQR 5 to 6) in
patients with T-tube group. The difference in the pain based on visual analog scale between
groups was statistically not significant (p-value 0.423) (Table 15 & Figure 17).
Table 14: Comparison of median value of pain (visual analog scale) between the two
groups (N=32)
Group
Parameter Primary Closure T- tube Mann Whitney
Median(IQR) Median(IQR) U test (P value)
Pain: visual analog scale (IQR) 6 (5 to 6) 5.50 (5 to 6) 0.423
Figure 20 : Bar chart of comparison of median value of pain (visual analog scale) between
the two groups (N=32)
6.1
6
6
Pain visual an a log scale (Median)
5.9
5.8
5.7
5.6
5.5
5.5
5.4
5.3
5.2
E. WOUND CELLULITIS
In primary closure group 5 (31.25%) patients had wound cellulitis. In t-tube group 7
(43.75%) patients had wound cellulitis. The difference in the proportion of wound cellulitis
between groups was statistically insignificant (p-value= 0.465) (Table 16 & Figure 18).
63
Observations
Table 15 : Comparison of group with wound cellulitis of study population (N=32)

Group
Chi square P-value
Wound Cellulitis Primary Closure T- tube
(N=16) (N=16)
Yes 5 (31.25%) 7 (43.75%)
0.533 0.465
No 11 (68.75%) 9 (56.25%)
Figure 21 : Comparison of wound cellulitis between the two groups (N=32)
50%
43.75%
45%
40%
35% 31.25%
30%
25%
20%
15%
10%
5%
0%
F. POST-OPERATIVE HOSPITAL STAY
The patients were discharged on the 9th day at average in the primary closure
group, while in the T-tube they were discharged on the 13th day on average. This difference
was statically significant (p-value <0.001) (Table 13 & Figure 16).
Table 16 : Comparison of duration of hospital stay between the two groups (N=32)
Post-operative Group
hospital stay Primary Closure T- tube
(days)
Independent sample t-test
Mean ± SD 9.00 ± 0.81 12.87 ± 1.40
p-value <0.001
Mann Whitney U test
Median (IQR) 9 (8.25 to 10) 13 (12 to 14)
p-value <0.001
64
Observations
Figure 22 : Comparison of mean post - operative hospital stay in (days) between the two
study groups (N=32)
14 12.87
Post operative hospital
12
10 9
stay (days)
8
6
4
2
0
G. HOSPITAL EXPENSES
The mean hospital expense in the primary closure group was lower at
₹ 39203.75 ± 6369.84 than ₹ 43153.13 ± 4841.85 of the T-tube group, the difference being
statistically significant (p-value= 0.032) (Table 19 & Figure 20). This correlates with a
significant (p-value= 0.004) positive correlation (Pearson correlation r=0.492) between
duration of hospital stay and total expense.
Table 17: Comparison of hospital expenses between the two study groups (N=32)
Group Mann-
Whitney U-
Primary Closure T- tube test
Parameter (Mean ±SD) (Mean ±SD) p-value
Hospital expenses ₹ 39203.75 ± 6369.84 ₹ 43153.13 ± 4841.85 0.032
Figure 23 : Bar chart of comparison of hospital expenses rupees between the two study
groups (N=32)
44000 ₹ 43,153.13
Hospital expenses (Mean)
43000
42000
41000
40000 ₹ 39,203.75
39000
38000
37000
65
DISCUSSION
Discussion
The liver is a large lobed glandular organ responsible for detoxification, metabolism,
synthesis and storage of various substances. Bile production is one of the most important
functions of the liver2. Choledocholithiasis is the presence of stones in the common bile
duct. It occurs in about 10–15% of patients with gallbladder stones4 and literature suggests
that common bile duct stones are encountered in approximately 7–15% of patients
undergoing cholecystectomy5. Endoscopic removal of the common bile duct stone is the
commonly used method to treat stones in the common bile duct where facilities are
available. Surgical procedures are followed in most centres. Following exploration,
traditionally, the CBD is repaired over a T-tube is placed through the longitudinal
choledochotomy6 7 8. On removal of the T-tube after 10 -12 day after CBD exploration, there
is the potential theoretical issue of bile leak through this opening into the peritoneal cavity.
But, fortunately, this opening is straddled by the fibrous tract formed around the tub,
forming a potential bilio-cutaneous fistula. Following the surgical adage, this hole and the
fistula-tract spontaneously heal, if there is no distal obstruction. Though there are a few
reports of complications specifically associated with the use of T-tube for biliary drainage9
10, choledochotomy followed by T-tube has long been a standard surgical treatment for
choledocholithiasis. It is still a preferred choice in many hospitals where minimal invasive
procedures are not feasible. But maintaining the T-tube choledochostomy entails several
problems for the patient.
To mitigate these problems, the idea of primary repair of choledochotomy, without

T-tube insertion, was promulgated. Previous studies comparing primary closure with T-
tube drainage in open techniques13 showed a significant reduction in hospital stay and
duration of operation while the complication rates were comparable in the two groups.
Thus, we planned a prospective, interventional study on patients who attended the

Surgery OPD of the Central Referral Hospital, associated to Sikkim Manipal Institute of
Medical Sciences admitted for surgical management of obstructive jaundice due to
choledocholithiasis.
A sample size of 32 was estimated based on previous studies as detailed on page

45. They were recruited over 16 months from January 2017 to April 2018 and evaluated
clinically and sonologically. A standard surgical protocol was followed for each patient as
67
Discussion
detailed on page 46. Intraoperatively, confirmation of clearance of CBD was done by rigid
cholangioscopy, and patency of common bile duct was confirmed by intraoperative
cholangiogram.
Patients with common bile duct diameter more than 15mm were included in
primary closure group while those with common bile duct diameter less than 15mm were
included in T- tube drainage group. The efficacy, safety and feasibility of primary closure of
common bile duct versus T-tube drainage in patients undergoing choledocholithotomy
were compared.
Demographics
A total of 32 patients were included in the final analysis equally divided into two
groups of 16 each operated by either primary closure of common bile duct or T-tube
drainage. Both the groups were comparable in terms of mean age, gender and BMI.
A. GENDER AND WEIGHT:
The proportion of females was significantly higher in primary closure group (87.5%)
compared to T tube group (37.5%) and this could have also accounted for the significant
difference in mean weight between the groups as men tend to weigh higher than women.
These differences were seen despite allocating groups based solely on CBD diameter as
determined intraoperatively.
The gender proportion observed in our study was at variance with that of Ambreen
M et al52 and Williams JA et al13 who reported that the difference in sex distribution was
statistically insignificant in the two groups.
B. MEAN AGE:
The difference in mean age between the two study groups was 4.1 years in the
study by Ambreen M et al52 and it was statistically insignificant. Williams JA et al13 also
found no significant difference between the groups in terms of age. In the current study
the mean age in primary closure group was 40.81, while it was 47.5 years in T-tube group.
This observed difference of 6.7 years was statistically insignificant.
68
Discussion
Pre-operative parameters
A. CLINICAL PRESENTATION AND CO-MORBIDITIES:
In our study, both the groups were comparable in terms of clinical presentation,
associated co-morbidities and presentation, similar to that of Ambreen M et al52 and
Williams JA et al13. There was no difference in proportion of patients presenting with biliary
colic, acute cholecystitis, jaundice between the two groups and also co-morbidities like
diabetes mellitus and hypertension.
B. PRE-OPERATIVE LABORATORY PARAMETERS:
The difference in the mean pre-operative laboratory parameters like hemoglobin,

total leucocyte count, total bilirubin, direct bilirubin and alkaline phosphatase were
statistically not significant between the two groups in the current study, similar to the
findings of Ambreen M et al52 and Williams JA et al13.
C. SONOLOGICAL FINDINGS:
Ambreen M et al52 reported a significant difference based on sonological findings

in median number of stones between the two groups with an average of 2 stones in the
primary closure group compared to 4 in the T tube group.
In our study also, of the 32 patients enrolled, USG failed to confirm presence or
number of stones within the common bile duct in 10 patients. These patients were
therefore subjected to MRCP. There was no significant difference in proportion of patients
with single or multiple cholelithiasis between the two groups among these cases subjected
to USG or MRCP or both. But overall, multiple stones were more commonly found in T tube
group compared to primary closure group sonologically our study, similar to Ambreen’s
study.
The difference in mean common bile duct diameters in the study conducted by
Ambreen M et al52 was statistically insignificant. They reported that the mean common bile
duct diameter in primary closure group was 15.2 mm and 16.4 mm in the T-tube group.
Contrarily, in our study, the difference in mean CBD diameter (17.7 mm in the primary
69
Discussion
closure group and 13.5 mm in the T-tube group) was statistically significant (p-value
<0.001).
This difference in CBD diameter between the two groups may be explained by the
enrolment criteria of CBD diameter used in the current study (page 47). Other than this, the
two groups were similar in terms of demographic, anthropometric, and pre-operative
hematological and biochemical parameters.
Intra-operative and post-operative parameters

The duration of surgery and, as a corollary, the duration of anaesthesia, has a
significant bearing on the post-operative course of patients undergoing surgery. The post-
operative course of the patient after surgery involves management of drainage tubes,
nausea and vomiting, correction of biochemical parameters and wound complications. All
of these has a direct relation to the total cost of treatment, which can have a very important
influence in decision making regarding alternative choices available.
Open common bile duct exploration is still an important procedure for removal of
CBD stone. After the CBD exploration is performed and stones have been removed, the
choice lies between primary closure of duct and T-tube drainage. T-tube placement after
CBD exploration has long been a standard surgical practice for choledocholithiasis. The
main advantages of this modality lies in the provision of external biliary drainage till edema
of sphincter of oddi subsides and availability of a route for percutaneous removal of
retained bile duct stones. However, this technique is associated with significant
complications51. Primary closure of common bile duct leads to shorter operating time, less
duration of stay at hospital, and devoid of complications like tube dislodgement, fracture
of tube, encrustation etc. Nevertheless, T-tube can also act as a foreign body around which
bile pigments and salts may precipitate51.
A. MEAN DURATION OF OPERATION:
In our study, the mean total duration of the surgery was 132.4 minutes in primary
closure group while it was 146.3 minutes in the T-tube group. This difference of around 14
minutes between two groups was statistically significant with a p-value of <0.001. Similar
70
Discussion
to our study Mokarram Ali MD et al51 also reported a significantly higher duration of surgery
by about 30 minutes in T tube compared to primary closure.
Thus it can be concluded that though both groups are comparable on account of
pre-operative parameters, the duration of surgery is lesser if CBD is closed primarily.
B. THE SUB-HEPATIC DRAIN:
In our study, although the output from the sub hepatic drain was statistically
comparable between the two groups, the drain was removed 3 days earlier in the primary
closure group (9 days) compared to T-tube group (12 days), the difference being statistically
significant. None of the patients in either group had any related complication or
requirement for any further biliary tract intervention.
Similar to our study, Williams JA et al13 also observed a difference of 2 days between
the groups. In T-tube drainage of the bile via drain continued for a median of 7 days
postoperative. In the primary closure group bile drained via the drain in 35% of the patients
for a median of 5 days.
Thus, it can be asserted that primary CBD closure and or its closure over T-tube are
similar in terms of drain output; while drain can be removed earlier in cases who undergo
primary closure as compared to T-tube closure.
C. POST – OPERATIVE COMPLAINS:
The median post-operative pain 6 hours post-operatively assessed by visual analog

scale was similar at 6 in the primary closure group and 5.5 in the T-tube group.
In primary closure group 43.8% of patients had post-operative nausea and / or

vomiting compared to 50% in the T-tube group, the difference being was statistically
insignificant (χ²-test p-value = 0.723).
Other studies comparing repair of CBD primarily or over T-tube did not provide
details regarding pain or PONV.
The causes of post-operative pain and PONV are various and varied, and mode of
CBD close does not seem to have an effect on their outcome.
71
Discussion
D. POST – OPERATIVE LABORATORY PARAMETERS:
The goal of choledocholithotomy is relief of biliary obstruction, which should be

reflected by reduction in serum bilirubin levels. In our study, 72 hours after surgery, the
total bilirubin level came down to 1.09 and 1.02 mg/dL respectively in primary closure and
T-tube group, from a pre-operative values of 6.23 and 4.79 mg/dL. The differences between
the two groups were statistically insignificant (p-value >0.05).
Similar to our study Ambreen M et al52 in their study did not find any significant
difference between the two groups with respect to post-operative complications including
jaundice, though one of their patients in T-tube group developed jaundice due to blocked
T-tube (the jaundice gradually relieved after T-tube removal).
On the contrary, significantly higher post-operative serum bilirubin was observed

by Mokarram Ali MD et al51 in the T-tube group compared to primary closure group (1.47
mg/dl vs 0.82 mg/dl). Nevertheless, despite statistical significance, the values are not
alarming.
Thus, though there are conflicting results regarding post-operative bilirubin levels
after choledocholithotomy between the primary closure and the T-tube groups, the values
are essentially acceptable clinically. Furthermore, our study demonstrated an equivalent
result between the two groups.
E. WOUND CELLULITIS :
In our study in the primary closure group 31.25% of patients suffered wound
cellulitis compared to 43.75% in the T-tube group, but this difference between the two
groups was statistically insignificant (p-value= 0.465).
Mokarram Ali MD et al51 also reported a higher rate of infection in the T-tube group
(35%) compared to primary closure group (15%) and similar to our study their also was
statistically insignificant.
Wound cellulitis and infection rates are similar irrespective of the fact whether CBD
is repaired primarily or over a T-tube.
72
Discussion
F. POST-OPERATIVE HOSPITAL STAY:
Mokarram Ali MD et al51 reported a higher mean duration of stay at hospital by

about 6 days in the T-tube group (13.4 days) compared to primary closure group (7.0 days).
Ambreen M et al52 also reported a higher duration of stay in the T-tube group by a mean
of 8.5 days.
Similarly, in our study, the median duration of stay was more by about 4 days (p-
value <0.001) in the T-tube group (13 days) compared to the primary closure group (9 days).
Thus, it can be firmly asserted that following choledocholithotomy, primary CBD

closure offers a better chance of earlier discharge from hospital.
G. HOSPITAL EXPENSES:
The mean total hospital expense of ₹ 43,153 in the T-tube group was significantly
(p-value= 0.032) higher by ₹ 3,950 than the ₹ 39,203 of the primary closure group.
Ambreen M et al52, similar to our study, too reported a significantly higher cost of
treatment in the T-tube group (nearly 3 times higher in their study) compared to the
primary closure group (p<0.001).
In a developing country like India, with an annual per capita income of $167072 in
2016 (compared to a world average of $10321) this difference in expenditure has
significant implication not only for the family of the patient, but also has major impact on
public health. Early discharge from hospital means an early return to work, which further
has an indirect effect on the economic impact on the patient and the society.
There is a definite reduction of hospital expense if primary choledochorraphy is done

after choledocholithotomy, as compared to T-tube placement. The longer stay in the
hospital and the additional cost of postoperative cholangiography contribute to the
increased expense in T-tube group.
73
Discussion
Table : COMPARISON OF OUTCOME VARIABLES IN THE PRESENT STUDY WITH OTHER STUDIES:
DURATION OF POST OPERATIVE
SAMPLE SURGERY HOSPITAL STAY IN WOUND CELLULITIS
SIZE IN MINUTES DAYS / INFECTION
(n) (Mean±S.D) (Mean±S.D ) (%)
Primary
Primary
Primary
Primary
Closure
Closure
Closure
Closure
T-tube
T-tube
T-tube
T-tube
132.44 ± 146.31 ± 12.87 ± 31.25 43.7
Present study 16 16 9 ± 0.81
10.06 5.62 1.40 (Cellulitis)
Mokarram Ali MD 65.00 ± 95.25 ± 13.40 15 35
20 20 7 ± 1.75
et al51 14.05 9.66 ± 3.10 (Infection)
Williams JA et al13 37 26 - - 8 11 - -
13.6 ±
Ambreen M et al52 16 19 - - 5.1 ± 1.1 - -
2.3
Gurusamy75 165 159 7.9% 23.9%
8 16 11.1 ± 8.0 ± 0.4
Makinen 198973
2.9
Marwah 200412 20 20 87.8 116.7 4.4 15.4
40 40 10 12
Payne 198674
(median) (median)
37 26 120 120 8 11
Williams 199413
(median) (median) (median) (median)
All variables are expressed as mean with standard deviation or %. Studies reporting median have
been specified. Red colour indicates statistically significant difference between the groups.
Gurusamy KS et al75 in their systematic review observed higher morbidity, infection,

operating time, and hospital stay in T tube group compared to primary closure group. In
the group where primary closure was performed, subjects were discharged earlier and
were not burdened by a T-tube.
In the current study we found that though both groups are comparable in terms of
demographic, anthropometric, and pre-operative clinical and laboratory parameters, the
intra- and post-operative outcomes like duration of surgery, time to drain removal, wound
cellulitis, time to discharge, and total hospital expense favour primary closure of CBD.
74
Discussion
Limitation of the current study

 The current study is applicable only to open choledocholithotomy; findings may or
may not be applicable to laparoscopic choledocholithotomy.
 Lack of genuine randomization as segregation into two groups was done on the
basis of CBD diameter with a cut-off of 15 mm.
 Different methods (suture material and techniques) of primary closure of CBD
were not compared.
 Long term follow-up was not done residual or recurrent CBD calculi.
Recommendations
Primary choledochorraphy after open choledocholithotomy can be considered as a
safe option in selected patients in to order to try to expedite discharge of patient and
reduce hospital cost.
Further randomized studies are required to establish the validity of these findings.
75
SUMMARY AND CONCLUSION
Summary
A prospective interventional study was conducted from January 2017 to April 2018
to compare T-tube placement versus primary closure of common bile duct among patients
undergoing choledocholithotomy.
Of all the patients undergoing choledocholithotomy, 32 patients who consented to

inclusion in the study were enrolled after ruling out the exclusion criteria. At the end of the
study, the collected data was tabulated and analysed. The study revealed the following
findings:
A. PATIENT DEMOGRAPHICS:
 Mean age of the patients in our study population was 40.81 ± 15.08 years in
primary closure group while it was 47.5 ± 11.66 years in T-tube group.
 The proportion of females was significantly higher in primary closure group
(87.5%) compared to T-tube group (37.5%).
 Mean BMI was 26.85 with majority of the patients in the overweight range.
B. PRE-OPERATIVE FINDINGS:
a) Clinical:
There was no difference between the two groups in terms of incidence of biliary
coli, or co-morbidities like diabetes or hypertension.
b) Biochemical:
Majority of the patients presented with jaundice. In primary closure group 11
patients (84.6%) had jaundice while in T-tube group 12 (92.3%) had jaundice.
Mean total bilirubin of the two groups were 6.23 and 4.79 respectively.
c) Radiological:
Among the patients in primary closure group, the mean common bile duct
diameter based on USG was 17.71 mm and it was 13.58 mm in patients in T-tube
group.
C. OPERATIVE FINDINGS:
The mean total duration of the surgery was 132.44 minutes in primary closure
group while it was 146.31 minutes in T-tube group and this difference of around
14 minutes between two groups was statistically significant.
77
D. POST-OPERATIVE FINDINGS:
 72 hours after surgery, the mean alkaline phosphatase was significantly lower at
59.41 U/L in the primary closure group, than 93.06 U/L in the T-tube group.
 The sub-hepatic drain was removed significantly earlier in the primary closure
group (8th day) than the T-tube group (11 days).
 The mean duration of hospital stay was lesser at a median 9 days in the primary
closure group than 13 days in the T-tube; the difference between two groups was
statistically significant.
In the current study, patients in primary closure group had significantly shorter
operating time, lower post-operative alkaline phosphatase, shorter time for removal of
drain and earlier discharge from hospital.
78
Conclusion
Primary choledochorraphy is a safe option in selected patients undergoing
choledocholithotomy, provided CBD patency and clearance can be confirmed intra-
operatively.
It provides the advantages of:

 No inconveniencing of patient with a T-tube.
 Avoidance of need for review T-tube cholangiogram.
 Earlier sub-hepatic drain removal.
 Earlier discharge from hospital.
 Lesser cost of treatment.
This study needs to be backed up with further randomized studies to define the
clinical, laboratory and / or imaging criteria for optimal outcomes after primary closure of
CBD following choledocholithotomy.
79
MASTERCHART
MASTERCHART
Age
S.No Name H. no Sex DOA DOD HT(cm) WT(kg) BMI
(y)
Pinkey
1 589119 26 F 17.4.17 25.4.17 162 63.00 24.00
Bhutia
Radha
2 413893 34 F 5.5.17 12.5.17 158 62.00 24.80
Tamang
Shiva
3 625500 62 F 3.6.17 10.6.17 164 65.00 24.20
Kumari
Kishore
4 576565 40 F 6.1.17 15.1.17 168 78.00 27.60
Tamang
5 Kumari Rai 616816 63 F 8.9.17 17.9.17 162 75.00 28.60
Tshering
7 585031 31 F 22.8.17 31.8.17 160 72.00 28.10
Ongmu
8 Pooja Rai 431802 27 F 4.10.17 12.10.17 166 68.00 24.70
9 Manisha 643808 22 F 14.8.17 21.08.17 162 70.00 26.70
10 Renuka Rai 644931 55 F 12.6.17 20.6.17 163 78.00 29.40
14 Anand 693915 62 M 11.10.17 20.10.17 165 55.00 20.20
16 Thendup 408529 43 M 13.9.17 22.9.17 167 72.00 25.80
21 Mariyam 617351 26 F 12.12.17 21.12.17 166 69.50 25.20
24 Kaveri 680116 28 F 12.7.17 20.7.17 162 71.00 27.10
31 Songmit 665448 60 F 12.4.18 19.4.18 159 56.00 22.20
Renuka
26 680561 45 F 13.3.17 21.3.17 162 74.00 28.20
Lepcha
32 Prakash 387991 29 M 17.3.18 26.3.18 167 78.00 28.00
Damber
6 593813 67 M 21.1.18 4.2.18 166 80.00 29.00
Singh
11 Ravi Gurung 434153 32 M 12.2.17 24.2.17 164 82.00 30.50
12 Aftab 656704 41 M 11.4.18 25.4.18 170 80.00 27.70
13 Aita Subba 670173 45 M 17.8.17 30.8.17 164 76.00 28.30
15 Pemkit 643808 50 F 13.7.17 25.7.17 164 69.00 25.70
17 Puspham 603066 57 F 2.2.18 14.2.18 163 56.00 21.10
18 Ravi 434153 32 M 11.6.17 24.6.17 165 78.00 28.70
19 Kaaleswar 644341 74 M 10.2.18 22.2.18 166 82.00 29.80
20 Sewa 381991 50 F 4.1.18 17.1.18 164 69.00 25.70
22 Aasshiya 689040 43 F 11.11.17 24.11.17 165 67.00 24.70
23 Selvam 567431 56 M 13.4.17 23.4.17 159 71.00 28.10
25 Sudha 417621 36 F 12.2.17 23.2.17 165 71.00 26.10
27 Usha 654211 49 F 2.4.17 13.4.17 163 69.00 26.00
28 Jay 623477 41 M 19.5.17 29.5.17 164 79.00 29.40
29 Kumar 684930 40 M 3.7.17 15.7.17 165 83.00 30.50
30 Suyog 693915 47 M 11.10.17 23.10.17 166 87.00 31.60
Mean-overall 44.18 163.88 72.11 26.85

Mean-Primary 41.06 163.24 69.44 26.06
Mean-T-tube 47.50 164.56 74.94 27.68
p value unpaired
0.17 0.15 0.05 0.08
t-test
81
MASTERCHART
Cholecystiti
Phosphatas
Number of
Biliary colic
Hemoglobi
diameter -
USG (mm)
Leucocyte
Jaundice
Common
Bile Duct
S.No
Bilirubin
Bilirubin
Stones -
Alkaline
Pre Op
Pre Op
Acute
Direct
count
Total
Total
HTN
USG
DM
CBD
n
e
s
1 YES NO YES NO NO 11.30 7700 10.00 6.00 261 16.60 Multiple
2 NO YES YES NO NO 11.50 3200 5.50 2.40 246 16.70 Solitary
3 YES NO NO NO NO 12.80 7800 7.00 3.40 550 17.80 Solitary
4 NO NO YES NO NO 13.80 9800 7.80 4.20 410 17.60 Solitary
5 YES NO NO NO NO 13.50 7500 0.40 0.25 258 15.90 Multiple
7 NO YES YES NO NO 11.10 9200 17.82 7.80 780 25.70 Solitary
9 NO NO YES NO NO 14.50 9300 7.20 4.10 344 15.30 Multiple
10 YES NO YES NO YES 12.60 8600 4.20 2.40 265 15.30 Multiple
14 YES NO YES YES YES 14.80 7800 3.40 1.90 326 16.30 Solitary
16 YES NO NO YES NO 17.10 5600 3.80 2.50 248 15.50 Solitary
21 NO YES YES NO NO 13.90 11400 6.40 4.20 485 24.00 Multiple
24 NO YES YES NO NO 15.70 12300 5.00 3.30 346 19.00 Multiple
31 YES NO NO NO YES 13.90 7700 10.10 5.80 181 18.30 Solitary
26 YES NO YES NO YES 15.30 8300 3.20 2.80 290 17.50 Solitary
6 YES NO NO NO YES 13.90 7700 1.11 0.40 81 14.30 Multiple
13 NO NO YES NO YES 15.60 8400 14.00 7.50 467 13.30 Multiple
15 NO YES YES YES YES 16.80 11800 4.80 2.60 344 12.30 Multiple
17 NO NO YES YES YES 15.20 7900 4.80 3.20 290 12.00 Multiple
19 YES NO YES YES YES 11.20 4200 5.50 3.80 415 14.70 Multiple
20 NO YES YES YES NO 12.30 12300 3.90 3.00 294 13.80 Multiple
27 YES NO NO NO YES 12.90 8600 1.00 0.70 155 13.00 No stone
28 YES NO NO NO YES 13.70 5600 1.00 0.40 140 11.50 No stone
29 NO NO YES NO YES 13.90 8900 12.00 7.90 258 12.00 Multiple
14.05 8015 5.53 3.33 310.39 15.69

13.76 8106 6.23 3.54 341.24 17.79
14.36 7919 4.79 3.11 277.63 13.46
0.28 1 0.30 0.56 0.17 0.00
82
MASTERCHART
No of Common
Cholangioscopy
Intra-operative
Post-Operative
Post-Op DB 72
Post-Operative
cholangiogram
Post- Op TB 72
duct diameter
Total duration
of the surgery
Concomitant
Common bile
Hospital Stay
Concomitant
Stones - MRI
CBD closure
Analog Scale
Pain - Visual
Post-op ALP
Gallstones -
Gallstones -
Sounding /
- MRI (mm)
/Vomitting
S.No
(minutes)
Bile Duct
flushing
Nausea
(days)
USG
MRI
hrs
hr
1 Present Clear Clear Clear Primary 142 9 NO 7 3.0 1.5 42
2 Present 16.3 Solitary Present Clear Clear Clear Primary 155 8 NO 6 1.0 0.28 48
3
Absent 15.7 Solitary Clear Clear Clear Primary 110 8 YES 6 1.20 0.24 32
4
Present Clear Clear Clear Primary 130 9 YES 6 1.80 0.60 110
5
Present 15.4 Multiple Present Clear Clear Clear Primary 138 10 YES 6 0.35 0.20 38
7
8 Present 17.5 Multiple Present Clear Clear Clear Primary 135 9 NO 6 0.40 0.25 36
10
14
21 Present 22.6 Multiple Present Clear Clear Clear Primary 121 10 NO 5 0.80 0.20 94
31
Absent Clear Clear Clear Primary 136 8 YES 5 0.40 0.10 54
26 Present 17.0 Solitary Present Clear Clear Clear Primary 128 9 NO 6 0.60 0.20 46
6
Present Clear Clear Clear T-tube 146 15 YES 5 0.40 0.15 54
11 Present Clear Clear Clear T-tube 155 13 NO 6 1.20 0.40 74
12
15
17
19
20
22 Absent Clear Clear Clear T-tube 144 14 NO 5 0.60 0.30 46
23 Present 13.9 Multiple Present Clear Clear Clear T-tube 146 11 NO 7 0.70 0.20 86
27
Present 12.5 Multiple Present Clear Clear Clear T-tube 138 12 YES 5 0.40 0.50 24
28 Present 11.0 Solitary Present Clear Clear Clear T-tube 156 11 NO 6 0.30 0.10 24
30
Present 15.6 Multiple Present Clear Clear Clear T-tube 143 13 YES 4 1.10 0.20 112
Mean-overall 15.8 139 11 5.6 1.05 0.38 75.73

Mean-Primary 17.3 132 9.06 5.7 1.09 0.43 59.41
Mean-T-tube 13.2 146 13.0 5.5 1.02 0.33 93.06
p value unpaired
t-test 0.02 0.00 0.00 0.2 0.74 0.32 0.03
83
MASTERCHART
DAILY SUB-HEPATIC DRAIN OUTPUT
DAY 13 ( ml )
DAY 10(ml )
DAY 12(ml )
DAY 11 (ml)
DAY 1 ( ml )
DAY 2 ( ml )
DAY 3 ( ml )
DAY 4 ( ml )
DAY 5 ( ml )
DAY 6 ( ml )
DAY 7 ( ml )
DAY 8 ( ml )
DAY 9 ( ml )
DAY 14(ml)
S.No
1 160 175 180 110 55 45 35 30

2 225 210 155 115 65 30 25
3 270 185 165 150 70 65 40
4 205 160 90 85 60 70 55 40 35
5 100 80 75 25 20 20 15 25 20
7 110 90 100 110 40 50 25 20 20
8 90 75 60 75 40 35 20 20
9 110 80 60 65 30 25 15
10 90 70 55 35 20 15 10
14 180 155 75 60 70 55 40 25 20
16 135 90 85 70 75 60 45 30 15
21 110 75 60 55 70 65 50 35 15
24 145 110 90 75 50 35 30 15
31 75 60 45 30 25 15 10
26 125 110 90 75 60 35 20 15
32 115 90 75 50 35 30 20 15 10
6 120 100 25 50 45 50 25 20 25 15 10 15
11 80 95 65 60 50 65 45 40 25 20 15
12 110 75 70 75 60 45 30 25 15 10 15 15
13 125 110 90 85 80 65 50 35 20 15 10 15
15 125 110 90 105 95 80 65 40 25 20 15 15
17 110 170 155 110 80 65 40 35 20 15 10
18 125 130 110 90 75 70 45 25 15 10 15 10
19 110 125 90 65 60 45 40 30 20 15 10 10
20 150 90 85 55 40 45 30 25 15 10 10 10 10
22 130 90 75 70 65 40 45 20 15 10 10 15
23 110 90 75 60 55 40 35 20 15 10
25 130 90 75 70 55 40 25 15 10 15 10
27 110 90 75 60 45 30 25 15 10 10 15
28 135 110 85 70 60 45 30 20 15 10
29 160 125 90 75 70 50 35 20 15 10 15 10
30 155 130 115 95 80 55 40 15 10 10 10 10
12.8
Mean-overall
131.9 110.7 88.48 74.39 56.36 45.91 32.73 24 17.61 1 12.14 12.50 10
Mean-Primary 139.4 113.2 91.18 74.12 49.71 40.29 27.94 23 19.29 -n/a- -n/a- -n/a- -n/a-
12.8
Mean-T-tube
124.0 108.1 85.63 74.69 63.44 51.88 37.81 25 16.88 1 12.14 12.50 10
p value
unpaired t-
test 0.28 0.69 0.64 0.95 0.03 0.04 0.03 0.7 0.48 -n/a- -n/a- -n/a- -n/a-
84
MASTERCHART
DAILY T-TUBE DRAIN OUTPUT
DAY 10 ( ml )
DAY 11 ( ml )
DAY 12 ( ml )
DAY 13 ( ml )
DAY 1 ( ml )
DAY 2 ( ml )
DAY 6 ( ml )
DAY 7 ( ml )
DAY 8 ( ml )
DAY 9 ( ml )
DAY 3 ( ml )
DAY 4 ( ml )
DAY 5 ( ml )
S.No
1
2
3
4
5
7
8
9
10
14
16
21
24
31
26
32
6 400 600 520 500 400 300 220 150 50
11 130 270 320 440 370 220 160 120 90
12 90 290 360 390 410 280 210 160 110 115 90
13 125 160 260 320 370 390 410 280 160 110 75
15 150 110 230 265 240 310 260 180 110 90 75
17 150 190 210 245 260 290 160 110 90
18 130 110 190 230 245 290 280 260 140 110 90
19 140 110 240 320 365 290 200 160 130 90 75
20 225 180 240 210 160 190 170 130 110 90 110
22 135 220 235 240 270 290 210 170 130 90 70
23 120 170 190 230 290 310 240 160 90
25 140 190 210 160 125 110 100 90 75
27 160 190 210 175 150 130 100 90 75
28 180 210 235 190 160 110 90 75 60
29 210 240 190 175 190 160 140 130 110 90 85
30 245 205 230 195 170 130 110 90 75
Mean- 215.3
overall 170.63 1 254.38 267.81 260.94 237.50 191.25 147.19 100.31 98.13 83.75
Mean-
-n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a-
Primary
Mean-T- 215.3
tube 170.63 1 254.38 267.81 260.94 237.50 191.25 147.19 100.31 98.13 83.75
p value
unpaired -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a- -n/a-
t-test
85
MASTERCHART
TIME TO REMOVE DRAIN
Acute biliary peritonitis
Acute biliary peritonitis

after T-tube removal
Biliary Leak 72 Hours
after drain removal

TIME TO REMOVE T
Acute Pancreatitis
Hospital Expenses
Wound Cellulitis
S.No
TUBE [days]
(Rupees )
[days]
1 8 NO NO NO YES ₹ 43,200.00
2 7 NO NO NO NO ₹ 38,600.00
3 7 NO NO NO NO ₹ 32,400.00
4 9 NO NO NO NO ₹ 43,500.00
5 9 NO NO NO YES ₹ 42,500.00
7 9 NO NO NO NO ₹ 51,500.00
8 8 NO NO NO NO ₹ 52,500.00
9 7 NO NO NO YES ₹ 42,400.00
10 7 NO NO NO YES ₹ 36,400.00
14 9 NO NO NO YES ₹ 38,600.00
16 9 NO NO NO NO ₹ 36,400.00
21 9 NO NO NO NO ₹ 37,300.00
24 8 NO NO NO NO ₹ 32,500.00
31 7 NO NO NO NO ₹ 32,100.00
26 8 NO NO NO NO ₹ 32,600.00
32 9 NO NO NO NO ₹ 34,760.00
6 12 9 NO NO NO NO YES ₹ 57,500.00
11 11 9 NO NO NO NO YES ₹ 43,200.00
12 12 11 NO NO NO NO YES ₹ 41,300.00
13 12 11 NO NO NO NO YES ₹ 45,600.00
15 12 11 NO NO NO NO NO ₹ 43,400.00
17 11 9 NO NO NO NO NO ₹ 41,200.00
18 12 11 NO NO NO NO NO ₹ 43,250.00
19 12 11 NO NO NO NO YES ₹ 46,700.00
20 13 11 NO NO NO NO YES ₹ 47,600.00
22 12 11 NO NO NO NO NO ₹ 41,250.00
23 10 9 NO NO NO NO NO ₹ 36,700.00
25 11 9 NO NO NO NO NO ₹ 42,100.00
27 11 9 NO NO NO NO YES ₹ 39,800.00
28 10 9 NO NO NO NO NO ₹ 37,600.00
29 12 11 NO NO NO NO NO ₹ 43,500.00
30 12 9 NO NO NO NO NO ₹ 39,750.00
Mean-overall 9.79 10.00 ₹ 40,918.48

Mean-Primary 8.12 ₹ 38,815.29
Mean-T-tube 11.56 10.00 ₹ 43,153.13
p value
p value Mann Whitney U-test
unpaired t-test 0.00 ₹ 0.03
86
ANNEXURE
Annexure
87
ANNEXURE
Study proforma
DEMOGRAPHICS
NAME OF THE PATIENT
HOSPITAL NO.
AGE/GENDER
DOA
DOD
SYMPTOMS
1.Biliary Colic
2.Acute Cholecystitis
3. Jaundice
Co-morbities
A) Diabetes Mellitus
B) Hypertension
Pre-operative Hemoglobin : Pre-operative Total Leucocyte count
Pre-operative Liver Function Test
1.Total Bilirubin
2.Serum Glutamic-pyruvic transaminase
3.Alkaline Phosphatase
Common bile duct diameter
Number of Common Bile Duct Stones
Concomitant Gallstones
Total duration of the surgery (minutes)
Hospital Stay (days)

Cost of Treatment
Biliary Leak
Post-operative Jaundice
Retained Stone
Recurrence of Common Bile Stones
88
ANNEXURE
Patient information sheet

You Mr./Mrs./MS……………………………………………Hospital no………………………… are being
asked to be a participant in the study mentioned below. I want you to read the following
carefully before agreeing your participation into the study.
RESEARCH BEING DONE: A prospective, interventional study to compare the T tube
placement and primary closure of common bile duct in patients undergoing
choledocholithotomy.
PURPOSE OF THE RESEARCH: To compare the T tube placement and primary closure of
common bile duct in patients undergoing choledocholithotiomy
EXPECTED DURATION OF SUBJECTS PARTICIPATION: You won’t be hospitalized for any extra
duration because of participation in study.
PROCEDURE INVOLVED: The preoperative, intraoperative and postoperative parameters
will be recorded as per Performa.
PRIVACY AND CONFIDENTIALITY: Privacy of the individual will be respected and any
information about you or provided by you during the study will be kept strictly confidential.
PROBABILITY FOR RANDOM ASSIGNMENT: Randomization, as described earlier, will be
employed in the study
REIMBURSEMENT FOR ANY EXPENSES: There is no provision any reimbursement for any of
your expenditure as your participation does not involve any extra expenses
WHOM TO CONTACT: For any queries, rights of Subjects and in the event of any enquiry
contact Dr. Md Nazar Imam (9523527693) and Dr. L. C. Chaudhary.
ANTICIPATED PRORATED PAYMENT: No anticipated prorated payment to the Subject for
participating in the trial.
YOUR RESPONSIBILITIES: There is no specific responsibility require from your side for study
DECLINE FROM PARTICIPATION: Participation is voluntary and you can withdraw from the
study at any time and that refusal to participate will not involve any penalty or loss of
benefits and you will be treated as per the existing protocol for your condition
BE REMOVED: Researcher can remove you from the study if circumstances arise.
COST OF PARTICIPATION: Participation is free of cost and there won’t be any extra cost for
participating in the study
WITHDRAWAL: To start with as the participation was voluntary so is the decision to
withdraw. Such a step will not alter the participant management by any staff in hospital.
NEW INFORMATION: All information collected during the study from participation will be
told as and when required
TOTAL NUMBER OF PATIENTS TO BE ENROLLED IN THE STUDY: Approximately 30.
89
ANNEXURE
Informed consent form

(i) I confirm that I have read and understood the information sheet dated for the above
study and have had the opportunity to ask questions.
(ii) I understand that my participation in the study is voluntary and that I am free to
withdraw at any time, without 'giving any reason, without my medical care or legal rights
being affected,
(iii) I understand that the Sponsor of the clinical trial, others working on the Sponsor's
behalf, the Ethics Committee and the regulatory authorities will not need my permission to
look at my health records both in respect of the current study and any further research that
may be conducted in relation to it, even if I withdraw from the trial. I agree to this access.
However, I understand that my identity will not be revealed in any information released to
third parties or published.
(iv) I agree not to restrict the use of any data or results that arise from this study provided
such a use is only for scientific purpose(s)
(v) I agree to take part in the above study.
Signature of the Subject/Legally Acceptable Representative
Signatory’s Name
Date
Investigator Signature
Investigator Name
Date
Witness Signature
Witness Name
Date
90
BIBLIOGRAPHY
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91
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SMIMS

A Prospective Interventional Study to C ompare

NATIONAL BOARD OF EXAMINATIONS

Dr. Md Nazar Imam

Topic: A prospective interventional study to compare the T-tube

Course: DNB (General Surgery)

Institution: Sikkim Manipal Institute of Medical Sciences, Gangtok

Board: National Board of Examination, New Delhi

Student: Dr. Md Nazar Imam

Guide: Dr Labanya Charan Choudhury, MS

Professor and Head of Department

Co-guide: Dr Kumar Nishant , DNB

Bile Duct in patients undergoing Choledocholithotomy” for the degree of Diplomate of

supervision of Dr. Kumar Nishant.

National Board in General Surgery.

: Head of the Department

The work contained in this thesis titled, “A Prospective, interventional study to

Dr. Md Nazar Imam

AIM AND OBJECTIVE .............................................................................................................

REVIEW OF LITERATURE .........................................................................................................

PATIENTS AND METHOD ...................................................................................................

MASTERCHART ........................................................................ ERROR! BOOKMARK NOT DEFINED.

7 Comparison of group with MRCP finding of study population (N=32) 65

12 Comparison of time to drain removal between the two groups (N=32) 70

16 Comparison of duration of hospital stay between the two groups (N=32) 72

17 Comparison of hospital expenses between the two study groups (N=32) 73

18 Comparison of outcome variables in the present study with other studies 82

2 Common bile duct and its divisions 14

3 Relation of common bile duct with adjacent organs 15

CBDS Common bile duct stones

EBD External biliary drainage

CBDE Common bile duct exploration

LCBDE Laparoscopic common bile duct exploration

PTCD Percutaneous transhepatic cholangiography drainage

RaR Rate ratio

RevMan Review Manager

TTF T-tube free

TTD T-tube drainage

ERC Endoscopic retrograde cholangiography

MRCP Magnetic resonance cholangiopancreatography

i. The duration of surgery

The earliest description of gallstones can be found in Alexandri Yatros Practica

Gabrielis Fallopia, in his book, Gabrielis falloppii Medici Mutinensis Observationes

Another major step forward was introduction of endoscopic retrograde

Common bile duct stone disease

The term choledocholithiasis refers to a condition when a gallstone or gallstones

bile duct stones are encountered in approximately 7–15% of patients undergoing

treatment have been dramatically altered. Today, laparoscopic cholecystectomy,

Genetic and environmental factors contribute to gallbladder disease. Female

Gallstones are generally asymptomatic. In the uncommon event that a patient

Common bile duct

The average length and

Figure 2: Common bile duct and its divisions

1. Bile ducts 12. Spleen.

Figure 3: Relation of common bile duct with adjacent organs

The supra-duodenal segment

The retroduodenal segment

The retropancreatic segment

The superior posterior-

With regards to structure and

Presentation and complication of choledocholithiasis***

The pathogenesis of stone formation is divided into three phases:

Hypersecretion of biliary cholesterol, crystallization promoting and inhibiting

Mixed gallstones: These gallstones are a combination of two or more substances,