Triveneta Udine, Aprile 2006 Il problema della definizione delle complicanze in chirurgia pancreatica

Prof. Claudio Bassi MD

Surgical and Gastroenterological Department

UNIVERSITY of VERONA

claudio.bassi@univr.it

spiffero!) in pancreatic surgery is the underlining phenomena of

Pancreatic fistula collections

Peripancreatic

Peripancreatic DGE

abscess

Bleeding

Pancreatic Fistula DO WE SPEAK THE SAME LENGUAGE?

Bassi C., Butturini G., Molinari E., Mascetta G., Salvia R., Falconi M., Gumbs
A. and Pederzoli P.

Pancreatic fistula rate after pancreatic resection. The importance of definitions

.

Dig Surg 21:54-59,2004.

Post-operative Pancreatic Fistula

A

Medline search of the last 10 years.

score was assigned to the reproducible definitions.

Post-operative Pancreatic Fistula

The

Medline search of the last 10 years identified 26 different definitions. definitions were found suitable for the applied score.

14/26

Score System
Score Output (cc/day) Timing *

1
2

>100
>50

>11
8-10

3
4

>25
>10

4-7
>4

* The sum between starting day and P.F.duration

Four final definitions summarizing the current pancreatic fistula concept according to the literature.
D1: Output more than 10cc/day of amylase rich fluid since 4th p.o day or for more than 4 days. (Score 7) D2: Output more than 10cc/day of amylase rich fluid since 8th p.o day or for more than 8 days. (Score 6)

D3: Output between 25 cc/day and 100cc/day of amylase rich fluid since 4th p.o day or for more than 4 days. (Score 5 and 4)
D4: Output more than 50 cc/day of amylase rich fluid since 11th p.o day or for more than 11 days. (Score 3)

Post-operative Pancreatic Fistula

The

4 definitions were applied to 242 pancreatic head resections with P-J carried out from 1997 to 2000 in our Institution.
Chi-Square test Yates correct test was than applied (p<0.05).

The

Incidence of pancreatic fistula in 242 patients using four different definitions Definition P.F.

D1: Output more than 10cc/day of amylase rich fluid 69 since 5th p.o day or for more than 5 days. (28.5%) D2: Output more than 10cc/day of amylase rich fluid 44 since 8th p.o day or for more than 8 days. (18.5%) D3: Output between 25 cc/day and 100cc/day of amylase 40 rich fluid since 4th p.o day or for more than 4 days. (16.5%)

D4: Output more than 50 cc/day of amylase rich fluid 24 since 11the p.o day or for more than 11 days. (9.9%)

GENTLEMAN AGREEMENT AMONG PANCREATIC SURGEONS!

upon an objective and internationally accepted definition to allow comparison of different surgical experiences!

POST OPERATIVE PANCREATIC FISTULA: CONSENSUS DEFINITION

Members of the International Study Group on Pancreatic Fistula Definition: Claudio Bassi (Verona, Italy), Christos Dervenis (Athens, Greece), Abe Fingerhut (Poissy, France), Charles Yeo (Baltimore, USA), John Neoptolemos MD (Liverpool, UK), Masayuki Imamura (Kyoto, Japan), Michael Sarr (Rochester, USA), William Traverso (Seattle, USA), Marcus Buchler (Heidelberg, Germany), Keith Lillemoe (Indianapolis, USA), Carlos Fernandez de Castillo (Boston, USA), Laureano Fernanadez Cruz (Barcelona, Spain), Clem Imrie (Glasgow, UK), Roland Andersson (Lund, Sweden), Dirk Gouma (Amsterdam, Netherland), Milicevic Miroslav (Belgrade, Yugoslavia), Andren Ake Sandberg (Gothemburg, Sweden), Tadahiro Takada (Tokio, Japan), Valerio Di Carlo (Milan, Italy), Jos Eduardo Cunha (San Paulo, Brasil), Rob Petbury (Adelaide, Australia), Helmut Friess (Heidelberg, Germany), Krzysztof Bielecki (Warsaw, Poland), Efthimios Chatzitheoklitos (Thessaloniki, Greece), Gregor Tsiotos (Athens, Greece), Colin Johnson (Southampton, UK), Mike Mac Mahon (Leeds, UK), Attila Olah (Gyor, Hungary), Tibor Tihani (Budapest, Hungary), Robin Williamson (London, UK), Jakob Izibicki (Hamburg, Germany), Giovanni Butturini

POST OPERATIVE PANCREATIC FISTULA: CONSENSUS DEFINITION Surgery 2005;138:8

A general definition of pancreatic fistula is an abnormal communication between the pancreatic ductal epithelium and another epithelial surface containing pancreas derived, enzyme - rich fluid. However POPF represents a failure of healing/sealing of a pancreatic-enteric anastomosis or it may represent a parenchymal leak not directly related to an anastomosis such as one originating from the raw pancreatic surface, e.g. left or central pancreatectomy, enucleation, and/or trauma. In this case there is a leak from the pancreatic ductal system into and around the pancreas and not necessarily to another epithelialized surface, e.g. a surgical drain.

FISTULA: CONSENSUS DEFINITION

Suspicion and diagnosis

The diagnosis of POPF may be suspected based on the many clinical or biochemical findings. A broad definition begins with the following criteria: output via an operatively-placed drain (or a subsequently placed, percutaneous drain) of any measurable volume of drain fluid with amylase content greater than three times the upper normal serum value. Drain fluid could have a sinister appearance that may vary from dark brown, to greenish bilious fluid, to milky water, to clear spring water that looks - like pancreatic juice. Associated clinical findings may include abdominal pain and distention with impaired bowel function, delayed gastric emptying, and fever > 38oC. Serum WBC > 10.000 cells/mm3 and increased C reactive protein may also be present. Radiologic documentation is neither mandatory nor necessarily recommended for diagnosis. However imaging may be useful by identifying erosion or migration of the drain into an enteric viscus and thus need for drain withdrawal to allow healing of the site of erosion.

sinister appearance? no! take it out as soon as possible!!

sinister appearance? yes! look to amylase content!

sinister appearance? yes! look to amylase and bacteria content!

FISTULA: CONSENSUS DEFINITION

Suspicion and diagnosis

The diagnosis of POPF may be suspected based on the many clinical or biochemical findings. A broad definition begins with the following criteria: output via an operatively-placed drain (or a subsequently placed, percutaneous drain) of any measurable volume of drain fluid with amylase content greater than three times the upper normal serum value. Drain fluid could have a sinister appearance that may vary from dark brown, to greenish bilious fluid, to milky water, to clear spring water that looks - like pancreatic juice. Associated clinical findings may include abdominal pain and distention with impaired bowel function, delayed gastric emptying, and fever > 38oC. Serum WBC > 10.000 cells/mm3 and increased C reactive protein may also be present. Radiologic documentation is neither mandatory nor necessarily recommended for diagnosis. However imaging may be useful by identifying erosion or migration of the drain into an enteric viscus and thus need for drain withdrawal to allow healing of the site of erosion.

Pancreatic fistula

Role of imaging
useful by identifying erosion or migration of the drain

2005;138:8

GRADE
Clincal Conditions

A
Well

B
Often well

C
Ill appearing or bad Yes Positive Yes
Yes

Specific treatment

No

Yes/No

US/CT Drain after 3 weeks Reoperatio n Death

Signs of Infections

Negative No
No

Neg//Pos Usually yes

No

No
No

No
Yes

Possibly yes Yes

Grade A Fistulas
10 Criteria are utilized to establish each grade Elevated Drain Amylase Persistent Drainage Signs of Infection Diagnostic Imaging Specific Treatments Readmission Critical Condition Re-operation Sepsis Death

Modified by Pratt et al. from Bassi C et al. Surgery 2005; 138: 813.

Grade B Fistulas
10 Criteria are utilized to establish each grade Elevated Drain Amylase Persistent Drainage Signs of Infection Diagnostic Imaging Specific Treatments Readmission Critical Condition Re-operation Sepsis Death

Modified by Pratt et al. from Bassi C et al. Surgery 2005; 138: 8-

Grade C Fistulas
10 Criteria are utilized to establish each grade Elevated Drain Amylase Persistent Drainage Signs of Infection Diagnostic Imaging Specific Treatments Readmission Critical Condition Re-operation Sepsis Death

Modified by Pratt et al. from Bassi C et al. Surgery 2005; 138: 813.

International Study Group on Pancreatic Fistula Definition

CONSENSUS DEFINITION Conclusion 1
Only

after clinical recovery is complete it is possible to ultimately distinguish and to grade the POPF as Grades A, B and C with respect to the clinical impact.

International Study Group on Pancreatic Fistula Definition

CONSENSUS DEFINITION Conclusion 2
The

present definition and clinical grading of POPF should allow realistic comparisons of surgical experiences in the future when addressing new techniques, new operations, or new pharmacologic agents that may impact surgical treatment of pancreatic disorders.

Clinical and Economic Validation of the International Study Group on Pancreatic Fistula Classification Scheme
Wande Pratt Shishir K. Maithel Tsafrir Vanounou Zhen Huang Mark P. Callery Charles M. Vollmer, Jr.
Department of Surgery Beth Israel Deaconess Medical Center Harvard Medical School Doris Duke Charitable Foundation

Clinical Validation on 176 Whipple

Clinically-Relevant Parameters
Hospital stay (LOS and readmission) Postoperative complications
Costs

Hospital Stay
40 30
p < .001
Days 20 (median)

35

10

13 8 8
Grade A Grade B Grade C No Fistula

0 ISGPF Grade

Complications
100%
p = .20

80% 60%

100% 76%
p < .05

Rate
40% 20% 0% No Fistula

37% 12%
Grade A Grade B Grade C

ISGPF Grade

Total Hospital Costs

$113.150
$120.000 $100.000 $80.000 Costs $60.000 (median) $40.000 $20.000 $0 No Fistula Grade A Grade B Grade C

p < .001

851.52$ 558.81$ $18.075

ISGPF Grade

Summary
ISGPF Classification Scheme
Grade A Fistulas are clinically insignificant Only Grade B and C fistulas are clinically significant

Clinical and Economic Validation

Increasing fistula severity impacts outcomes

A New Sub-Classification - ISGPF Scheme

Amylase-Rich vs. Amylase-Deficient Fistulas

Still open problem Does the drain fluid amylase contain reflect pancreatic leakege?
WE NEED INTERNATIONAL SHARING OF DATA

PRELIMINARY DATA FROM ONE SINGLE CENTRE

137 Evaluated Resections: No POPF VS POPF

PD: No POPF VS POPF

Left Pancreatctomy: No POPF VS POPF

Conteggio di fistola ams 1sx

2741 2800 3200

ams 5 sx
300 20 100 120 640 50 120 32 83 20 40 20 200 50 490 85 200 665 40 299 150 25 118 2958 0 170 618 1673 530 3140 35 1413 141 550 150 421 430 318 416 131 99 1000 2307 60 1370 70 31000 919 1900 66 2234 6390 50000

fistola2 NO
1 1 1 1

AMS in I e Vgg p.o. correlate

A B C Totale complessivo
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 128

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 101 12 1 11 4

3261 3300 3424 3470 3915 4141 4373 4470 5000 5131 5162 5200 6095 6336 7000 7197 7400 8000 8420 8656 8905 9370 10000 10250 10257 10507 10800 11989 13200 14478 14500 15264 16328 17610 18000 18141 19831 20000 27168 28000 40000 42000 47947 54969 58000 100000 Totale complessivo

1 gg p.o. ams < 4400 ams > 4400 ams >4400

5 gg.po qualsialsi valore >200 < 200

pz

fistola % 86 2 2,3256 27 27 100 15 0 0

Preliminary Conclusions
High risk with > than 4000 u/ml in the first p.o. day.

>200 u/ml in V p.o. day.

1 gg p.o. ams < 4400 ams > 4400 ams >4400 5 gg.po qualsialsi valore >200 < 200 pz fistola % 86 2 2,3256 27 27 100 15 0 0

HPB European Chapter, Verona June 2007