Modern Management of Common Bile Duct Stones

James Buxbaum,
KEYWORDS  Cholangiopancreatography  Endoscopic retrograde  Common bile duct gallstones  Biliary calculi  Lithotripsy  Sphincterotomy  Endoscopic  Balloon dilatation KEY POINTS
 Given lack of efficacy relative to endoscopic retrograde cholangiography (ERCP), pharmacologic therapy for bile duct stones should be reserved for patients who are not candidates for therapeutic procedures.  ERCP should be performed only if there is a high suspicion of bile duct stones; imaging studies for confirmation should be performed if there is intermediate suspicion, to minimize complications associated with ERCP.  ERCP with sphincterotomy, mechanical lithotripsy, and stent placement may be used to remove most bile duct stones; biliary endoscopists should be adept at precut techniques and the removal of impacted baskets from the duct.  Intraductal laser and electrohydraulic lithotripsy may be used to fragment most large bile duct stones, and their use will likely become more widespread with the introduction of single-operator cholangioscopes.  Balloon dilatation after endoscopic sphincterotomy is an effective technique for removal of large bile duct stones.  The approach to patients with concomitant bile duct stones and cholelithiasis depends on available laparoscopic surgical and biliary endoscopic expertise.
MD

INTRODUCTION

Each year more than 210,000 Americans are hospitalized for acute pancreatitis, for which bile duct stones are the leading cause.1 In addition, the acute increase in intraductal pressure by stone occlusion may drive bacteria into the bloodstream, resulting in septic cholangitis. Chronic obstruction may result in secondary biliary cirrhosis. It is imperative for gastroenterologists to understand the different formations of bile duct

Conflicts of interest: The author has nothing to disclose. Division of Gastrointestinal and Liver Diseases, Keck School of Medicine, Los Angeles County Hospital, University of Southern California, D & T Building Room B4H100, 1983 Marengo Street, Los Angeles, CA 90033-1370, USA E-mail address: jbuxbaum@usc.edu Gastrointest Endoscopy Clin N Am 23 (2013) 251275 http://dx.doi.org/10.1016/j.giec.2012.12.003 giendo.theclinics.com 1052-5157/13/$ see front matter 2013 Elsevier Inc. All rights reserved.

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stones and the various medical treatments that are available. To minimize the complications of endoscopic retrograde cholangiopancreatography (ERCP), it is critical to appropriately assess the risk of bile duct stones before intervention. Biliary endoscopists should be comfortable with the basic techniques of stone removal, including sphincterotomy, mechanical lithotripsy, and stent placement. It is also important to be aware of the advanced options, including laser and electrohydraulic stone fragmentation, as well as papillary dilatation for problematic cases. Finally, the timing and need for ERCP in those who require a cholecystectomy is a consideration.
GENESIS AND PHARMACOLOGIC THERAPY FOR BILE DUCT STONES

Medical therapy for gallstone disease was championed particularly in the 1970s and early 1980s. Interest has waned since the introduction of laparoscopic cholecystectomy and ERCP, whereby stones in the gallbladder and bile duct may be removed with low morbidity. Medical therapy aims to correct the biochemical anomalies that cause cholesterol and pigment stone formation. More recently, there has been keen interest in addressing and treating stone disease as part of the metabolic syndrome.
Formation of Cholesterol Stones

Most bile duct stones in patients with a healthy biliary tree result from the migration of stones from the gallbladder into the ductal system. Between 10% and 20% of patients with symptomatic cholelithiasis harbor bile duct stones.2 In the Western population, 80% of bile duct stones are cholesterol stones and 20% are pigment stones. The liver primarily eliminates cholesterol into the gut in the form of bile, which is aqueous. Hydrophobic cholesterol molecules are insoluble in this medium but are carried by phospholipids and bile salts that have both hydrophobic and hydrophilic moieties.3 Increases in the levels of cholesterol or decreases in amounts of phospholipids or bile salts results in the supersaturation and precipitation of cholesterol from the bile mixture. Gallbladder stasis promotes the progression of cholesterol crystallization into stones, thus accounting for increased rates of cholesterol stone formation during fasting and pregnancy (Fig. 1A).
Choleretics

Administration of the bile salts ursodeoxycholic acid and chenodeoxycholic acid decreases the saturation of cholesterol in bile indirectly by increasing the secretion of phospholipids and bile salts, and by directly reducing the absolute cholesterol secretion.4 Using bile salts to treat cholelithiasis yielded mediocre results.5 In the National Cooperative Gallstone Study, which randomized 900 patients with radiolucent (cholesterol predominant) stones to placebo, 40% of patients had a complete or partial dissolution of gallbladder stones.6 Controlled trials of ursodeoxycholic acid and chenodeoxycholic acid to treat bile duct stones consistently demonstrate modest efficacy with resolution of bile duct stones in, at most, 50% of patients.7,8 Chenodeoxycholic acid also has potential hepatotoxicity, which limits its use. Several studies suggest that adding Rowachol, which is a mixture of vegetable oils (terpenes), moderately enhances the efficacy of bile salts in the dissolution of ductal stones.9,10 Nonetheless, clinical studies also revealed that a high percentage (25%40%) of those undergoing medical therapy with bile salts and/or Rowachol develops complications of bile duct stones requiring hospitalization and surgery.7,11 Given the high efficacy of endoscopic and surgical stone removal, ursodeoxycholic acid and Rowachol should be reserved for the management of bile duct stones in special circumstances, such as for patients who are too compromised to undergo intervention or

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Fig. 1. Cholesterol stones (A) have a chalky yellow hue and mulberry appearance. Black pigmented stones (B) are discrete and faceted in contrast to brown stones (C, D), which are soft and form casts.

have unusual disease patterns that will not respond to interventional techniques, such as hepatolithiasis related to cystic fibrosis or Caroli disease. The use of these agents in conjunction with endoscopic stenting is explored later in this article.
Solvents

The injection of solvents into the gallbladder to dissolve gallstones was first performed in the nineteenth century.12 Thistle and colleagues13 reported resolution of 90% of cases of gallbladder stones following infusion of the powerful solvent methyl-tert-butyl ether (MTBE) via a percutaneous transhepatic catheter. However, the results were less favorable when it was introduced by Di Padova and colleagues14 into the bile duct to address choledocholithiasis. Complications, including peptic ulcer disease, somnolence, and vomiting, were encountered. It was proposed that unlike the closed space of the gallbladder, the biliary tree allows leakage of the solvent into the duodenum, where direct injury and systemic absorption occurs. Although MTBE results in the complete dissolution of bile duct stones in 25% of cases, 58% developed complications of abdominal pain, cholangitis, or lethargy. The somewhat milder solvent monooctanoin has also been studied for dissolution of cholesterol bile duct stones in a large uncontrolled study of 343 patients.15 It was helpful in 54% of cases, though definitely successful in only 26%; furthermore, 67% of patients developed side effects of pain, vomiting, and diarrhea. Solvent infusion into the bile duct has thus been limited by an adverse side-effect profile, and the approach has been largely abandoned in favor of more efficacious, better tolerated interventional methods.16

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Formation and Treatment of Pigment Stones

Bile is also the medium for clearing senescent blood cells through the excretion of its byproduct, bilirubin. Increased blood-cell destruction, as is seen in hemolytic anemia, overwhelms the livers ability to conjugate bilirubin, which precipitates with calcium to form black pigment cells (Fig. 1B). Black stones are also seen in alcoholism, old age, and cirrhosis. Patients with damaged intrahepatic ducts from recurrent pyogenic cholangitis, which is thought to be due to prior parasitic injury as well as primary sclerosing cholangitis and ischemia, develop recurrent suppurative infections. Bacterial b-glucuronidase hydrolyzes conjugated bilirubin, which then complexes with calcium and mixes with sloughed epithelium and cholesterol crystals to form brown pigment stones (Fig. 1C, D). Given the composition of pigment stones, they do not respond well to cholesterol desaturation therapy with bile salts and dissolution with solvents. Addition of agents that chelate or complex with calcium found in pigment stones, such as ethylenediaminetetra-acetic acid, modestly improves efficacy.17 However, a high rate of side effects of vomiting and diarrhea has limited their widespread use.
Relation to Metabolic Syndrome and Prevention

` -vis the hypermetabolic syndrome. There has been recent interest in gallstones vis-a A high-fat diet results in high serum triglyceride levels and bile becomes oversaturated with exogenous cholesterol, which causes gallstones.18 Studies have demonstrated that a high carbohydrate diet, a low high-density-lipoprotein level, and insulin sensitivity are also associated with gallstones.19,20 The high rates of gallstone formation in Native Americans has been attributed to thrifty genes that favored survival for their ancestors during the last ice age.21 Nonetheless, dietary and lifestyle factors still exert a potent influence.22 The prevalence of symptomatic gallstones in Pima Indians, who consume a Western diet, exceeds 50%. However, in the genetically similar Tarahumara Indians, who do not consume a high-fat, high-starch diet and are extremely physically active, gallstones are very rare.21 Therefore, the first step in the management of bile duct stones is to encourage patients to avoid high-fat, high-carbohydrate diets and a sedentary lifestyle. Recent work has also demonstrated that using statins, which lower cholesterol by inhibiting the cholesterol synthetic enzyme 3-hydroxy-3-methylglutaryl coenzyme A reductase, is associated with less symptomatic gallstone disease.23 The antihyperlipidemic ezetimibe, which prevents absorption of intestinal cholesterol, has also been shown to decrease biliary cholesterol saturation and crystallization in patients.24 Animal models suggest that it may also lower biliary cholesterol secretion and improve gallbladder motility by preventing cholesterol absorption by smooth muscle cells.
CLINICAL APPROACH TO BILE DUCT STONES

In the contemporary era, most bile duct stones are removed by ERCP and concomitant gallbladder stones are removed by laparoscopic cholecystectomy. Although it is the least invasive approach, ERCP for the removal of bile duct stones is associated with complications in 8% to 10% of patients.25 Thus it is critical that ERCP be used only for therapy and not diagnosis, which necessitates accurately assessing probability of bile duct stones.
Assessment of Probability of Bile Duct Stones

The transition from open cholecystectomy to laparoscopic approaches intensified interest in the preoperative predictors of choledocholithiasis. Removal of bile duct stones is straightforward during open cholecystectomy, but technically difficult to

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achieve laparoscopically.26 Biochemical tests are the least invasive method of assessing the probability of bile duct stones: alanine aminotransferase, aspartate aminotransferase, bilirubin, and alkaline phosphatase are correlated with the presence of bile duct stones and if none are elevated, the likelihood is less than 3%.27 However, the sensitivity and specificity of these individual laboratories are inadequate, and several groups have tried to identify combinations of biochemical tests that have a superior predictive capacity.2,2830 In the most widely cited study of the reliability of biochemical tests, Barkun and colleagues (Fig. 2) demonstrated that age older than 55 years, bilirubin level greater than 30 mmol/L (1.8 mg/dL), and bile duct dilatation greater than 6 mm best predicted common duct stones, with the probability being 92% if all are present. However, even patients thought to have a high probability of bile duct stones on the basis of ductal dilatation on ultrasonography or liver-test anomalies have been found at ERCP not to have bile duct stones in more than two-thirds of cases.31 Using removal of bile duct stones as the gold standard, magnetic resonance cholangiopancreatography
Suspected Choledocholithiasis (jaundice, pancreatitis with abnormal liver tests)

Abdominal Ultrasound (US) assess for common bile duct (CBD) stones and diameter

Low Probability Age <55, CBD <6 mm Bilirubin <1.5 mg/dl

Intermediate Probability CBD >6 mm OR Bilirubin >1.5 mg/dl

High Probability CBD stones OR

Age >55 AND CBD >6 mm AND Bilirubin >1.5 mg /dl

Magnetic Resonance Cholangiopancreatography (MRCP) or Endoscopic Ultrasound (EUS) to confirm common bile duct (CBD) stones

NO

YES

Laparoscopic Cholecystectomy (LC) with Intraoperative Cholangiogram (IOC) *

Endoscopic Retrograde Cholangiography with Stone Removal followed by LC OR LC with IOC and anticipated laparoscopic common duct exploration

* If gallbladder present

Fig. 2. Approach to bile duct stones based on clinical suspicion. (Data from Refs.39,109,113)

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(MRCP) was found to be equally specific but more sensitive than ultrasonography (93% vs 30%) for bile duct stones because the distal duct is often obscured from sonographic visualization by intervening bowel gas.32 Studies have demonstrated that endoscopic ultrasonography (EUS), whereby the ultrasound probe is positioned immediately adjacent to the bile duct, has an accuracy and negative predictive value greater than 90% for choledocholithiasis.25,33 Therefore, EUS and MRCP may be used to confirm or exclude bile duct stones with reasonable confidence (see Fig. 2).
Clinical Impact of Risk Stratification

Prospective studies have demonstrated that using MRCP and EUS to confirm or exclude bile duct stones minimizes complications in those with an intermediate probability of choledocholithiasis. Several groups have randomized patients with intermediate probability of bile duct stones to evaluation with ERCP or EUS followed by ERCP if stones are confirmed by endosonography.3437 These studies demonstrate that an EUS-based strategy avoids ERCP in 30% to 75% of patients.35 Polkowski and colleagues33,36 observed a trend toward more procedures in the EUS group compared with ERCP-based groups but significantly fewer complications; 8% versus 40%, driven by the much lower rate of adverse events in EUS (1.6%) compared with ERCP (12.5%). Nonetheless, EUS requires sedation and is associated with some, albeit low, procedural risk. Ainsworth and colleagues38 compared the performance of EUS and ERCP in a group of 163 patients with suspected stones. The accuracies of EUS and MRCP for stone detection and their abilities to predict the necessity of therapeutic ERCP were equivalent. An additional consideration is cost. Arguedes and colleagues39 demonstrated, using a decision analysis model, that the most cost-effective strategy of managing gallstone pancreatitis was highly dependent on the probability of bile duct stones. Cholecystectomy with intraoperative cholangiography (IOC) was favored when the probability of bile duct stones was less than 10%, EUS when the probability was 10% to 50%, and ERCP when the probability was greater than 50%. In another prospective series of 463 patients managed with an EUS-based approach, ERCP was avoided in 216 patients, and the total cost was significantly less than it would have been if an ERCP-based approach had been used.40
ENDOSCOPIC REMOVAL OF BILE DUCT STONES

In the era of laparoscopic cholecystectomy, ERCP with sphincterotomy has achieved primacy in the management of bile duct stones. Sphincterotomy, mechanical lithotripsy, and stent placement are the fundamental techniques. If used appropriately, the biliary endoscopist may remove 80% to 90% of stones and may expect complications in fewer than 10% of cases.
Asymptomatic Stones

Patients who present with symptomatic bile duct stones have a greater than 50% chance of developing recurrent biliary pain, jaundice, or cholangitis; these complications are serious in 25% of cases.41 Patients who have asymptomatic stones have a more benign clinical course. A large series of patients with cholelithiasis but minimal preoperative risk for bile duct stones were randomized to undergo IOC versus not to undergo IOC.42 Unexpected stones were encountered in 12% of those who underwent IOC. The patients who were not randomized to IOC presumably had a similar frequency of an asymptomatic bile duct stone. Over the course of 3 years of followup, none of these patients developed biliary symptoms. In addition, spontaneous

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stone migration may be seen in approximately 20% of cases, particularly for small (<8 mm) stones.43 Nevertheless, given the potential for serious complications, it is advised that bile duct stones are removed unless the patients comorbidities make the procedure prohibitively high risk.44
Sphincterotomy

Although it was initially espoused only for patients who are poor candidates for surgery, with the advent of laparoscopic cholecystectomy endoscopic sphincterotomy has emerged as the primary modality for access to and removal of bile duct stones. In a classic study from the London Middlesex Hospital, sphincterotomy was used to manage biliary obstruction from suspected stones in 1000 consecutive patients and enabled successful endoscopic drainage in 985 (Fig. 3A).45 Stones were confirmed in 797 patients and removed by balloon and basket sweep in 85% (Fig. 3B, C). In this initial report, sphincterotomy was complicated by bleeding in 4%, cholangitis in 2%, pancreatitis in 1%, and perforation in 1%. Subsequent large series have reported comparable complication rates for sphincterotomy for choledocholithiasis.4648 Large trials have demonstrated that the risk of sphincterotomy for bile duct stones (8.1%) is significantly lower than for other indications including dysfunction of sphincter of Oddi (20.4%), driven largely by the risk of pancreatitis.46 In addition, sphincterotomy complications decrease with the increased experience of the endoscopist.47

Fig. 3. After an adequate sphincterotomy (A) (note a juxtapapillary diverticulum), sweeps with extraction balloons (B) and dormia baskets (C) can be used to remove most bile duct stones.

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Most perforations during stone removal are retroduodenal and, in contrast to free perforations, can be managed by conservative measures (see Fig. 3A, B).49 Postsphincterotomy bleeding can be controlled by injection of epinephrine, bipolar cautery, or argon plasma coagulation.50 The placement of large stents may effectively tamponade bleeding and enable biliary drainage (see Fig. 3C). In some cases, it is necessary to extend the sphincterotomy during a subsequent procedure. It appears that there is a lower rate of pancreatitis but comparable rates of bleeding in such procedures in comparison with the initial sphincterotomy.51 Some endoscopists have expressed concerns about the long-term effects of sphincterotomy, particularly for young patients. However, long-term follow-up data suggest that problems are unusual: subsequent biliary symptoms are seen in 12% to 13% and sphincter stenosis in 4% to 7%.52,53 Furthermore, late biliary problems typically respond well to endoscopic treatment.53
Needle-Knife and Rendezvous Techniques

Sphincterotomy is classically performed using a catheter with a bowing wire (see Fig. 3A). After engagement of the biliary orifice, cutting is typically performed in the 11- to 12-oclock direction along the axis of the duct (Fig. 4A). However, for challenging

Fig. 4. Cholangiograms (A, B) demonstrate retroperitoneal leakage of contrast after sphincterotomy for bile duct stones. The patient responded to stent placement and conservative treatment. After sphincterotomy, hemorrhage occurred (C), but was controlled by placement of an Amsterdam type stent (D).

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cases a needle knife may be used to unroof the bile duct and enable access. In a large series of 694 patients who underwent precut sphincterotomy for biliary access, Rabenstein and colleagues46,48 demonstrated that the maneuver was successful in 85% of those who failed conventional access techniques. In contrast to prior work, they reported that complications of needle-knife papillotomy were not significantly higher than in conventional sphincterotomy (7.3% vs 6.8%). The investigators suggest that inexperienced operators and the delayed use of needle-knife techniques only after excessive failed attempts to access the bile duct account for the greater complication rates reported by other groups. Patients who present with a crowning stone impacted in the papilla are particularly amenable to needle-knife excision, given the difficulty of advancing a sphincterotome into the meatus. Often the needle-knife excision will result in a prompt, satisfying expulsion of the biliary concretion (Fig. 5A, B).54 In addition, in patients with situs anatomy, such as those who have undergone a Billroth II surgery, conventional sphincterotomes will not cut in the appropriate 5- to 6-oclock direction; however, this may be accomplished using a needle knife (Fig. 5C). There are 2 approaches to needle-knife papillotomy. In the conventional approach, a cut in the direction of the bile duct is

Fig. 5. A needle knife is used to unroof a crowning stone (A), which leads to its spontaneous expulsion (B). Needle-knife lithotripsy is used perform a sphincterotomy in a patient with inverted anatomy consequent to Roux-en-Y gastric bypass surgery (C). A percutaneously placed wire (D) is used to guide cannulation after an initial ERCP was unsuccessful because of failed cannulation.

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made from the papillary meatus. In the fistulotomy approach, the papillary mound is incised and a cut made toward, but typically not to, the meatus. Randomized data suggest the fistulotomy approach is more likely to require subsequent mechanical lithotripsy but is less likely to cause pancreatitis.55 Access may be achieved in those who fail precut techniques by rendezvous procedures whereby a wire is introduced percutaneously. Endoscopic cannulation can then be performed immediately adjacent to or over the percutaneous wire (Fig. 5D). Recently EUS has been used to introduce the guide wire in an anterograde fashion, enabling an entirely endoscopic rendezvous approach.56
Mechanical Lithotripsy

Mechanical lithotripsy is the favored technique to fragment and remove large stones with diameters that exceed the size of the maximal allowable sphincterotomy.57 The stones are fractured between the basket and sheath covering the wire by closing the basket handle (Fig. 6A). Crushing very hard or large stones requires a coiled metal sleeve. This procedure is most easily performed by using an all-inclusive lithotripsy device, which contains a basket, plastic sheath, flexible metal coil sleeve, and an

Fig. 6. A soft stone is crushed between a basket and standard sheath (A). Hard-pigment type stones required the use of an all-inclusive lithotripsy system. The flexible metal sleeve is introduced into the duct (B), and is used to crush the stone (C) and remove the hard fragments (D).

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attachable cranking apparatus (Fig. 6BD).58 When aggressive mechanical lithotripsy is not anticipated and the stone and extraction basket become impacted together, an extraendoscopic lithotripter may be used (Fig. 7).58 The success of mechanical lithotripsy varies with stone size and papillary anatomy, but ranges from 84% to 99%.57,5962 Chang and colleagues59 report that the risk of a single session of mechanical lithotripsy is comparable with sphincterotomy. However, if multiple sessions are necessary the rates of pancreatitis, bleeding, and cholangitis increase significantly. Complications unique to mechanical lithotripsy include basket impaction and malfunction.63 If the impacted basket and stone cannot be freed by crushing the stone with the extraendoscopic lithotripter, a variety of maneuvers including sphincterotomy extension, stent placement, and stone fragmentation by extracorporeal shock-wave lithotripsy (ESWL) or laser lithotripsy may be used.6366 Bile duct exploration with removal of the stone and basket may also be performed surgically. Use of the extraendoscopic lithotripter may result in trauma to the mucosa of the gastric incisura, angle of the duodenum, and papilla by the exposed basket wires.58
Biliary Stent Placement

Another alternative for the management of more difficult cases is biliary stent placement. This technique was initially espoused for older patients with comorbidities.67 Bergman and colleagues68 reported on a cohort of 117 patients with median age of 80 years, all of whom underwent successful biliary drainage by stent placement. Complications

Fig. 7. The extraendoscopic emergency lithotripter is assembled by cutting the handle off of the dormia basket (A) and removing the plastic sheath. The back of the metal coil sleeve (B) is then attached to the cranking device, and the tip is fed over the exposed basket wire (C). As the metal coil sleeve is advanced toward the ampulla the wire emerges through the back and into the lithotripter, and is fastened to the cranking device (D), which is turned to crush the stone.

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occurred in 10% of patients in whom stenting was used as a temporary measure before further endoscopic therapy or surgery. For those patients who received stents as permanent therapy, problems were unusual during the first year; however, complications associated with the stents, which were not routinely exchanged, exceeded 50% thereafter. Most importantly, 16% of the patients in this group died of infectious biliary complications. Several trials have randomized high-risk patients to aggressive ductal clearance versus long-term plastic stent placement, and the results are consistent with those of Bergman and colleagues.69,70 Although the short-term morbidity attributable to the procedural complications was somewhat greater in clearance groups, the long-term morbidity was significantly higher in the stent groups because of high rates of cholangitis. Although stents have fallen out of favor as destination therapy, recent work demonstrates that temporary stent placement facilitates stone removal.71 Jain and colleagues72 managed a series of patients with large stones by pigtail-stent placement. When the stents were removed 6 months later, there were no residual stones in half of the patients (Fig. 8). In a cohort of patients with large (>2 cm) or multiple (>3) stones, pigtail stents were placed and, when they were removed 2 months later, the stone burden in the group decreased by greater than 50% and clearance was achieved in 93%.73 Given that the size reduction was more prominent in those with multiple rather than single stones, the mechanism of action was proposed to involve the friction between stents and stones. It is likely that multiple stents could further facilitate stone grinding and removal. Covered metal stents, which exert greater radial force, have been used with success in a single series of 36 patients, but have not been compared with plastic stents.74 There has been growing interest in administering oral choleretic medications in addition to stent placement for large stones after initial reports suggesting that they accelerate the dissolution of ductal stone.75,76 Katsinelos and colleagues77 randomized patients with challenging biliary stones to stent placement followed by treatment with ursodeoxycholic acid or stent placement followed by placebo. At 6 months, the patients were reassessed by ERCP; there was no difference in ductal clearance or stone burden between the 2 groups. The impact of adding a combination of Rowachol and terpene to inserting biliary stents has also been studied in a controlled trial, in which there was no significant difference in stone burden or successful duct clearance between those randomized to receive the choleretic regimen and those who did not receive the medications.78

Fig. 8. Two pigtail stents are placed under endoscopic (A) and fluoroscopic (B) guidance to decompress an elderly patient with giant bile duct stones. The duct was cleared in a subsequent laser lithotripsy procedure.

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ADVANCED ENDOSCOPIC TECHNIQUES FOR CHALLENGING BILE DUCT STONES

The management of difficult bile duct stones is a formidable challenge for the biliary endoscopist and has been the subject of extensive contemporary endoscopic research. Stone fragmentation may be accomplished by ESWL and intraductal methods of fragmentation, including electrohydraulic and laser lithotripsy. Intraductal treatment may be guided by fluoroscopy or choledochoscopy. Over the past decade, papillary balloon dilatation after endoscopic sphincterotomy has been introduced as a technique to address challenging stones.
Features of the Difficult Stone

Conventional techniques can fail because of features of the stone and papillary region. The most significant predictor of failed mechanical lithotripsy is the impaction of the stone in the bile duct, which prevents the opening of the lithotripsy basket and encircling of the stone (Fig. 9A).57 Barrel-shaped and piston-shaped stones, as well as those that arise from the cystic duct takeoff, are difficult to manipulate (Fig. 9B, C). Perivaterian diverticulum (see Fig. 3A) and inverted papillary orientation, as is seen following Billroth II (Fig. 11A) or Roux-en-Y (see Fig. 5C) gastric bypass surgeries, make biliary access and sphincterotomy difficult. Finally, bile duct anomalies, including distal tapering or a sigmoid shape, also make stone removal challenging.79

Fig. 9. Bile duct stones may be difficult to remove owing to impaction (A), large size (B), or piston shape (C), which limits manipulation of the mechanical basket.

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Extracorporeal Shock-Wave Lithotripsy

ESWL was developed to address nephrolithiasis and is frequently used to manage calcified pancreatic duct stones. In classic ESWL, shock waves that are generated by electric discharges outside of the body are transmitted to the patient, who is submerged in a water bath. This approach has progressed from the original electrohydraulic designs, which required general anesthesia, to piezoelectric, electromagnetic, and focused electrohydraulic lithotripters, which use a fluid-filled cushion rather than a bath. Because modern lithotripters deliver focused shock waves, general anesthesia is unnecessary. Large series have demonstrated ductal clearance in patients with refractory stones from 83% to 100%, with complications reported in 6% to 9%.8084 Nevertheless, ESWL is typically guided by fluoroscopy; therefore, ERCP is required before the procedure to place a nasobiliary drain for the contrast agent, and also afterward to clear debris.82
Intraductal Shock-Wave Techniques

In electrohydraulic lithotripsy (EHL), a bipolar electrode probe is guided into the bile duct by either fluoroscopy or cholangioscopy.70 High-voltage electric sparks discharged from the probe create a shock wave, and continuous irrigation with saline provides the medium for intraductal conduction. Cholangioscopic-guided and fluoroscopic-guided EHL have been used to clear bile duct stones in 77% to 90% of cases.85,86 Complications occurred in 6% to 18%, mostly recurrent jaundice or cholangitis. For the past 2 decades, lasers have also been used under fluoroscopic or cholangioscopic guidance to fragment large bile duct stones. Light-energy absorption from the surface of the stone creates an expanding plasma cloud, and the resulting mechanical shock wave fragments the stone (Fig. 10). A variety of lasers, including

Fig. 10. The cholangioscope is advanced under endoscopic and fluoroscopic guidance to approach a very large stone (A). Under cholangioscopic guidance the laser is fired (B), and subsequent shock waves result in the fragmentation of the stone as seen by cholangioscopy (C) and fluoroscopy (D).

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doubled-double-pulse neodymium:YAG (FREDDY), flashlamp-pumped pulse, alexandrite, and holmium have been used, with ductal clearance reported in 73% to 94% of patients. Complications have occurred in 0% to 9.6%, with cholangitis being the most frequent adverse event.8793 The rhodamine-6G flashlamp-pumped pulsed laser is notable in that the probe has the ability to differentiate scattered light from tissue versus stone, and it will automatically shut off if the former is sensed.89,94
Comparison of Advanced Fragmentation Techniques

Several controlled trials have compared ESWL with the intraductal methods of stone disruption. These studies suggest that the efficacy of ESWL is comparable with intracorporeal EHL and fluoroscopic-guided laser lithotripsy, although cholangioscopicguided laser lithotripsy may be superior.86,95,96 In addition, these trials have consistently shown that ESWL requires more procedures. Although not controlled, comparison of misdirected pulses in fluoroscopic- versus cholangioscopic-laser lithotripsy suggests that the latter strategy is more accurate and less likely to induce tissue injury.89 Cholangioscopy may be performed through the papilla or percutaneously. However, when performed percutaneously, the resulting large biliocutaneous fistula is associated with bleeding and infection in 23% of cases, so the percutaneous approach should be reserved for exceptional cases of aberrant anatomy, strictures, and intrahepatic stones.88 During the past decade there have been significant developments in cholangioscopy. Early models required 2 expert endoscopists to drive mother-baby scopes that were awkward and fragile.95 Recently, however, several single-operator cholangioscopes with improved durability and maneuverability have been introduced.83,84 Preliminary studies indicate that they may be used to support intraductal laser and EHL, with favorable rates of ductal clearance.83,97 In addition, long-length, ultraslim cholangioscopes, which are advanced directly through the mouth, have been used to perform laser lithotripsy and EHL.90,93 Cholangioscopy is discussed further in a dedicated article elsewhere in this issue by Isaac and colleagues.
Papillary Balloon Dilatation Following Sphincterotomy

Recently the use of endoscopic balloon dilatation (EBD) has experienced a renaissance with the caveat that a sphincterotomy is first performed. EBD without sphincterotomy is viewed with caution, following the multicenter trial by Disario and colleagues.98 In this study, the investigators randomized 238 patients with bile duct stones to EBD versus endoscopic sphincterotomy. Although the efficacy was equivalent, 97.4% for EBD compared with 92.5% for sphincterotomy, there were more complications in the EBD group (17.9% vs 3.3% in the sphincterotomy group), predominantly related to high rates of pancreatitis in the former group. There were 2 fatalities in the EBD group, both due to pancreatitis. These results differed somewhat from a prior trial by Bergman and colleagues,99 in which sphincterotomy and EBD had similar efficacy for stone removal and an equivalent modest rate of pancreatitis. Nonetheless, the population was much older in the Bergman trial (72 years compared with 47 years in the trial by Disario and colleagues), and the complication rates after EBD (18%) and endoscopic sphincterotomy (23%) were both high. A meta-analysis by Baron and Harewood100 found that although the efficacy of both methods appeared equivalent, the rate of pancreatitis after EBD (7.4%) was significantly higher than the rate following sphincterotomy (4.3%). However, more bleeding was seen after endoscopic sphincterotomy (2%) than after EBD (0%). Given the risk of pancreatitis, EBD is no longer recommended

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for most stone cases, except those with a very high risk of hemorrhage, such as in cirrhotic patients with coagulapathy.101 A recently introduced approach is performing EBD immediately after sphincterotomy in patients not successfully treated with conventional techniques.102 This method is promising in patients with large complex stones and those with narrow distal ducts.79,102,103 In a multicenter study, EBD after sphincterotomy for bile duct stones achieved stone clearance in 95% of patients, and there were no episodes of pancreatitis.104 The investigators postulated that the biliary sphincterotomy separates the biliary from the pancreatic orifice, and the subsequent force of dilatation is preferentially directed toward the sphincterotomy and away from the pancreatic duct. Experts also suggest that the risk of perforation can be minimized by placing two-thirds of the balloon in the bile duct and one-third outside, to dilate the papillary orifice and duct in a unidirectional manner.103 Stefanidis and colleagues105 randomized patients to endoscopic sphincterotomy followed by mechanical lithotripsy or to sphincterotomy followed by EBD. The methods were equally effective for stone removal, both greater than 90%, but there were significantly more complications, primarily cholangitis, in the lithotripsy group. In addition, retrospective data suggest that endoscopic sphincterotomy combined with dilatation requires less mechanical lithotripsy, fluoroscopy time, and procedure time.106 Endoscopic sphincterotomy followed by EBD is also particularly suited for patients in whom it is treacherous to perform a large sphincterotomy, such as those with diminutive papilla or inverted anatomy (see Fig. 11).107 New devices, including

Fig. 11. Cholangiography was performed in a patient with an inverted papilla (A) after Billroth II surgery, revealing a ductal stone (B). Given the diminutive papilla and aberrant anatomy a small sphincterotomy was performed, and large balloon dilatation (C) facilitated stone removal (D).

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a sphincterotome equipped with a large-diameter balloon, may further improve the efficiency of this method.108
APPROACH TO BILE DUCT STONES IN THE PATIENT WITH AN INTACT GALLBLADDER

The widespread introduction of ERCP and laparoscopic cholecystectomy has generated controversy regarding the best approach to patients with symptomatic bile duct stones and an intact gallbladder. Laparoscopic approaches to the bile duct are challenging and time consuming. Comparing the 2-stage approaches of ERCP along with laparoscopic cholecystectomy (Fig. 12) with laparoscopic cholecystectomy and laparoscopic common duct exploration (LCBDE) has been the subject of ongoing study and debate.
Laparoscopic Removal of Bile Duct Stones Versus ERCP

At the time of laparoscopic surgery, bile duct stones may be removed by the straightforward transcystic approach or by the technically demanding choledochotomy. In a recent series, Nathanson and colleagues109 managed a cohort of 372 patients with choledocholithiasis who underwent laparoscopic cholecystectomy. Transcystic clearance was successful in 286. The remaining patients were randomized to either choledochotomy or postoperative ERCP. Operating time was greater in the cholecystectomy and choledochotomy group, 152.7 minutes, compared with the cholecystectomy-alone group, 102.8 minutes. However, when factoring in the ERCP time, the overall procedure time was similar in the 2 groups: 158.8 minutes for choledochotomy group compared with 147.9 minutes for the ERCP group.
Outcomes of Single Versus 2-Stage Approach to Simultaneous Choledocholithiasis and Cholelithiasis

Several trials have compared the clinical outcomes of the 2-stage approach with those of the single-stage strategy. Rogers and colleagues110 randomized 122 patients to laparoscopic cholecystectomy plus LCBDE or to ERCP with sphincterotomy plus

Fig. 12. A bile duct stone seen on ERCP after laparoscopic cholecystectomy.

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laparoscopic cholecystectomy. Although the techniques had equivalent efficacy and safety, the length of hospitalization was 2 days fewer for those who underwent the combined laparoscopic procedure. Rhodes and colleagues111 randomized 427 patients with bile duct stones found on cholecystectomy to either laparoscopic exploration or postoperative ERCP. Consistent with the work of Rogers and colleagues, Rhodes and colleagues found that rates of ductal clearance and safety were comparable, but there was a longer median hospital stay (3.5 days) in the ERCP group, compared with 1 day in the LCBDE group. In both trials, patients with cholangitis and severe pancreatitis were excluded and proceeded directly to ERCP. Recently, Lu and colleagues112 performed a meta-analysis of 9 randomized trials that compared 2-stage ERCP and laparoscopic cholecystectomy with combined laparoscopic cholecystectomy and bile duct exploration. In the total group of 787 patients, the approaches were found to have equivalent efficacy and safety. The longer hospital stay seen in the ERCP group in the individual trials was not evident; however, significantly more procedures were required in the ERCP group than in the combined laparoscopic group. The problem with applicability of these data, however, is that most surgeons do not have the training to perform LCBDE.
Timing of ERCP in Relation to Laparoscopic Cholecystectomy

The timing of ERCP, either before or after the cholecystectomy, is debated. Some surgeons advocate preoperative ERCP so that surgery may be performed in patients who have undergone unsuccessful biliary endoscopy. In expert centers, operative removal of bile duct stones was required in 6.6% of patients who failed ERCP; however, additional operations were needed in 7.3% of those who underwent surgery to remove bile duct stones. Thus, additional procedures are unusual but may be required after unsuccessful ERCP or surgical removal of bile duct stones.109 The optimal timing of ERCP and laparoscopic surgery is best guided by local availability and technical expertise.
SUMMARY

Bile duct stones are a source of significant morbidity, given their association with pancreatitis and cholangitis. Medical therapy for cholesterol and pigment bile duct stones aims to correct the biochemical aberrancies that lead to their formation. Hydrophilic bile salts and Rowachol decrease the biliary cholesterol supersaturation that underlies the formation of cholesterol stones. However, the modest efficacy of these agents relative to minimally invasive endoscopic and surgical interventions limits their use to exceptional circumstances. Significant side effects have limited the use of solvents for cholesterol stones and chelators for pigment stones. Lifestyle measures, such as avoidance of high-cholesterol and carbohydrate diets, and the future role of statins and ezetimibe are areas of active investigation in the prevention of gallstones. Although accurate, ERCP is not recommended for the diagnosis of bile duct stones because of the significant risk of complications. Liver tests, clinical presentation, patients age, and biliary dilatation can help stratify the probability of bile duct stones. Both EUS and MRCP may be used to confirm the presence of a bile duct stones in people with an intermediate probability of stones. Prospective studies indicate that using these technologies to confirm the need for ERCP in this group prevents complications and is likely a more cost-effective approach. Removing bile duct stones is recommended for both symptomatic and asymptomatic stones, although asymptomatic stones may be observed in prohibitively high-risk patients. Endoscopic sphincterotomy followed by balloon and basket sweeps of the

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bile duct is successful in the majority of patients. Precut sphincterotomy and fistulotomy are important techniques that are best performed by an experienced endoscopist. For more difficult stones, mechanical lithotripsy is helpful, but the operator must be capable of managing basket and stone impaction. Stent placement is also useful for difficult cases. Temporary stent placement is very effective in achieving decompression and reducing stone size, and permanent stent therapy is associated with prohibitively high rates of cholangitis. There is insufficient evidence to recommend medical therapy as an adjunct to stent placement. Certain stone, duct, and papillary features may cause widely available endoscopic techniques to be unsuccessful in removing the concrements. Advanced methods are required to remove large or odd-shaped stones as well as those in patients with narrow distal ducts and diminutive papillae. ESWL, intraductal laser, and electrohydraulic therapy may be used to fragment and remove difficult stones, although ESWL requires more procedures than do intraductal techniques. Expense and technical equipment have limited the use of these techniques to patients seen in specialized referral centers. However, a new generation of single-operator cholangioscopes will likely enable the more widespread use of fragmentation techniques. EBD alone is not recommended because of high rates of pancreatitis; however, balloon dilatation after sphincterotomy appears to be effective and safe. In patients with bile duct stones and an intact gallbladder, both ERCP and laparoscopic common duct exploration are effective, although the latter approach requires fewer procedures. However, local availability and expertise in laparoscopic versus endoscopic techniques are currently the dominant factors that govern the management strategy at individual institutions.
ACKNOWLEDGMENTS

Special thanks are extended to Richard Molina, Kelvin Yeh, MD, and Arthur Yan, MD for assisting with figures.
REFERENCES

1. Fagenholz PJ, Castillo CF, Harris NS, et al. Increasing United States hospital admissions for acute pancreatitis, 1988-2003. Ann Epidemiol 2007;17(7):4917. 2. Trondsen E, Edwin B, Reiertsen O, et al. Prediction of common bile duct stones prior to cholecystectomy: a prospective validation of a discriminant analysis function. Arch Surg 1998;133(2):1626. 3. Paumgartner G, Sauerbruch T. Gallstones: pathogenesis. Lancet 1991;338(8775): 111721. 4. von Bergmann K, Epple-Gutsfeld M, Leiss O. Differences in the effects of chenodeoxycholic and ursodeoxycholic acid on biliary lipid secretion and bile acid synthesis in patients with gallstones. Gastroenterology 1984;87(1): 13643. 5. Iser JH, Dowling H, Mok HY, et al. Chenodeoxycholic acid treatment of gallstones. A follow-up report and analysis of factors influencing response to therapy. N Engl J Med 1975;293(8):37883. 6. Schoenfield LJ, Lachin JM. Chenodiol (chenodeoxycholic acid) for dissolution of gallstones: the National Cooperative Gallstone Study. A controlled trial of efficacy and safety. Ann Intern Med 1981;95(3):25782. 7. Sue SO, Taub M, Pearlman BJ, et al. Treatment of choledocholithiasis with oral chenodeoxycholic acid. Surgery 1981;90(1):324.

270

Buxbaum

8. Salvioli G, Salati R, Lugli R, et al. Medical treatment of biliary duct stones: effect of ursodeoxycholic acid administration. Gut 1983;24(7):60914. 9. Ellis WR, Bell GD. Treatment of biliary duct stones with a terpene preparation. Br Med J (Clin Res Ed) 1981;282(6264):611. 10. Leiss O, von Bergmann K. Effect of Rowachol on biliary lipid secretion and serum lipids in normal volunteers. Gut 1985;26(1):327. 11. Somerville KW, Ellis WR, Whitten BH, et al. Stones in the common bile duct: experience with medical dissolution therapy. Postgrad Med J 1985;61(714):3136. 12. Walker J. The removal of gallstones by ether solution. Lancet 1891;137:8745. 13. Thistle JL, May GR, Bender CE, et al. Dissolution of cholesterol gallbladder stones by methyl tert-butyl ether administered by percutaneous transhepatic catheter. N Engl J Med 1989;320(10):6339. 14. Di Padova C, Di Padova F, Montorsi W, et al. Methyl tert-butyl ether fails to dissolve retained radiolucent common bile duct stones. Gastroenterology 1986;91(5):1296300. 15. Palmer KR, Hofmann AF. Intraductal mono-octanoin for the direct dissolution of bile duct stones: experience in 343 patients. Gut 1986;27(2):196202. 16. Diaz D, Bories P, Ampelas M, et al. Methyl tert-butyl ether in the endoscopic treatment of common bile duct radiolucent stones in elderly patients with nasobiliary tube. Dig Dis Sci 1992;37(1):97100. 17. Neoptolemos JP, Hofmann AF, Moossa AR. Chemical treatment of stones in the biliary tree. Br J Surg 1986;73(7):51524. 18. Grunhage F, Lammert F. Gallstone disease. Pathogenesis of gallstones: a genetic perspective. Best Pract Res Clin Gastroenterol 2006;20(6):9971015. 19. Tsai CJ, Leitzmann MF, Willett WC, et al. Glycemic load, glycemic index, and carbohydrate intake in relation to risk of cholecystectomy in women. Gastroenterology 2005;129(1):10512. 20. Petitti DB, Friedman GD, Klatsky AL. Association of a history of gallbladder disease with a reduced concentration of high-density-lipoprotein cholesterol. N Engl J Med 1981;304(23):13968. 21. Carey MC, Paigen B. Epidemiology of the American Indians burden and its likely genetic origins. Hepatology 2002;36(4 Pt 1):78191. 22. Katsika D, Grjibovski A, Einarsson C, et al. Genetic and environmental influences on symptomatic gallstone disease: a Swedish study of 43,141 twin pairs. Hepatology 2005;41(5):113843. 23. Tsai CJ, Leitzmann MF, Willett WC, et al. Statin use and the risk of cholecystectomy in women. Gastroenterology 2009;136(5):1593600. 24. Wang HH, Portincasa P, Mendez-Sanchez N, et al. Effect of ezetimibe on the prevention and dissolution of cholesterol gallstones. Gastroenterology 2008; 134(7):210110. 25. Prat F, Amouyal G, Amouyal P, et al. Prospective controlled study of endoscopic ultrasonography and endoscopic retrograde cholangiography in patients with suspected common-bileduct lithiasis. Lancet 1996;347(8994):759. 26. Cotton PB, Baillie J, Pappas TN, et al. Laparoscopic cholecystectomy and the biliary endoscopist. Gastrointest Endosc 1991;37(1):947. 27. Yang MH, Chen TH, Wang SE, et al. Biochemical predictors for absence of common bile duct stones in patients undergoing laparoscopic cholecystectomy. Surg Endosc 2008;22(7):16204. 28. Robertson GS, Jagger C, Johnson PR, et al. Selection criteria for preoperative endoscopic retrograde cholangiopancreatography in the laparoscopic era. Arch Surg 1996;131(1):8994.

Management of Bile Duct Stones

271

29. Del Santo P, Kazarian KK, Rogers JF, et al. Prediction of operative cholangiography in patients undergoing elective cholecystectomy with routine liver function chemistries. Surgery 1985;98(1):711. 30. Santucci L, Natalini G, Sarpi L, et al. Selective endoscopic retrograde cholangiography and preoperative bile duct stone removal in patients scheduled for laparoscopic cholecystectomy: a prospective study. Am J Gastroenterol 1996; 91(7):132630. 31. Tham TC, Lichtenstein DR, Vandervoort J, et al. Role of endoscopic retrograde cholangiopancreatography for suspected choledocholithiasis in patients undergoing laparoscopic cholecystectomy. Gastrointest Endosc 1998;47(1):506. 32. Laokpessi A, Bouillet P, Sautereau D, et al. Value of magnetic resonance cholangiography in the preoperative diagnosis of common bile duct stones. Am J Gastroenterol 2001;96(8):23549. 33. Canto MI, Chak A, Stellato T, et al. Endoscopic ultrasonography versus cholangiography for the diagnosis of choledocholithiasis. Gastrointest Endosc 1998; 47(6):43948. 34. Karakan T, Cindoruk M, Alagozlu H, et al. EUS versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a prospective randomized trial. Gastrointest Endosc 2009;69(2):24452. 35. Ang TL, Teo EK, Fock KM. Endosonography- vs. endoscopic retrograde cholangiopancreatography-based strategies in the evaluation of suspected common bile duct stones in patients with normal transabdominal imaging. Aliment Pharmacol Ther 2007;26(8):116370. 36. Polkowski M, Regula J, Tilszer A, et al. Endoscopic ultrasound versus endoscopic retrograde cholangiography for patients with intermediate probability of bile duct stones: a randomized trial comparing two management strategies. Endoscopy 2007;39(4):296303. 37. Lee YT, Chan FK, Leung WK, et al. Comparison of EUS and ERCP in the investigation with suspected biliary obstruction caused by choledocholithiasis: a randomized study. Gastrointest Endosc 2008;67(4):6608. 38. Ainsworth AP, Rafaelsen SR, Wamberg PA, et al. Is there a difference in diagnostic accuracy and clinical impact between endoscopic ultrasonography and magnetic resonance cholangiopancreatography? Endoscopy 2003;35(12):102932. 39. Arguedas MR, Dupont AW, Wilcox CM. Where do ERCP, endoscopic ultrasound, magnetic resonance cholangiopancreatography, and intraoperative cholangiography fit in the management of acute biliary pancreatitis? A decision analysis model. Am J Gastroenterol 2001;96(10):28929. 40. Buscarini E, Tansini P, Vallisa D, et al. EUS for suspected choledocholithiasis: do benefits outweigh costs? A prospective, controlled study. Gastrointest Endosc 2003;57(4):5108. 41. Caddy GR, Kirby J, Kirk SJ, et al. Natural history of asymptomatic bile duct stones at time of cholecystectomy. Ulster Med J 2005;74(2):10812. 42. Murison MS, Gartell PC, McGinn FP. Does selective peroperative cholangiography result in missed common bile duct stones? J R Coll Surg Edinb 1993; 38(4):2204. 43. Frossard JL, Hadengue A, Amouyal G, et al. Choledocholithiasis: a prospective study of spontaneous common bile duct stone migration. Gastrointest Endosc 2000;51(2):1759. 44. Caddy GR, Tham TC. Gallstone disease: symptoms, diagnosis and endoscopic management of common bile duct stones. Best Pract Res Clin Gastroenterol 2006;20(6):1085101.

272

Buxbaum

45. Vaira D, DAnna L, Ainley C, et al. Endoscopic sphincterotomy in 1000 consecutive patients. Lancet 1989;2(8660):4314. 46. Freeman ML, Nelson DB, Sherman S, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;335(13):90918. 47. Lambert ME, Betts CD, Hill J, et al. Endoscopic sphincterotomy: the whole truth. Br J Surg 1991;78(4):4736. 48. Rabenstein T, Ruppert T, Schneider HT, et al. Benefits and risks of needle-knife papillotomy. Gastrointest Endosc 1997;46(3):20711. 49. Kayhan B, Akdogan M, Sahin B. ERCP subsequent to retroperitoneal perforation caused by endoscopic sphincterotomy. Gastrointest Endosc 2004;60(5):8335. 50. Oviedo JA, Barrison A, Lichtenstein DR. Endoscopic argon plasma coagulation for refractory postsphincterotomy bleeding: report of two cases. Gastrointest Endosc 2003;58(1):14851. 51. Mavrogiannis C, Liatsos C, Papanikolaou IS, et al. Safety of extension of a previous endoscopic sphincterotomy: a prospective study. Am J Gastroenterol 2003;98(1):726. 52. Hawes RH, Cotton PB, Vallon AG. Follow-up 6 to 11 years after duodenoscopic sphincterotomy for stones in patients with prior cholecystectomy. Gastroenterology 1990;98(4):100812. 53. Sugiyama M, Atomi Y. Risk factors predictive of late complications after endoscopic sphincterotomy for bile duct stones: long-term (more than 10 years) follow-up study. Am J Gastroenterol 2002;97(11):27637. 54. Leung JW, Banez VP, Chung SC. Precut (needle knife) papillotomy for impacted common bile duct stone at the ampulla. Am J Gastroenterol 1990;85(8):9913. 55. Mavrogiannis C, Liatsos C, Romanos A, et al. Needle-knife fistulotomy versus needle-knife precut papillotomy for the treatment of common bile duct stones. Gastrointest Endosc 1999;50(3):3349. 56. Shah JN, Marson F, Weilert F, et al. Single-operator, single-session EUS-guided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla. Gastrointest Endosc 2012;75(1):5664. 57. Garg PK, Tandon RK, Ahuja V, et al. Predictors of unsuccessful mechanical lithotripsy and endoscopic clearance of large bile duct stones. Gastrointest Endosc 2004;59(6):6015. 58. Binmoeller KF, Schafer TW. Endoscopic management of bile duct stones. J Clin Gastroenterol 2001;32(2):10618. 59. Chang WH, Chu CH, Wang TE, et al. Outcome of simple use of mechanical lithotripsy of difficult common bile duct stones. World J Gastroenterol 2005;11(4): 5936. 60. Cipolletta L, Costamagna G, Bianco MA, et al. Endoscopic mechanical lithotripsy of difficult common bile duct stones. Br J Surg 1997;84(10):14079. 61. Schneider MU, Matek W, Bauer R, et al. Mechanical lithotripsy of bile duct stones in 209 patientseffect of technical advances. Endoscopy 1988;20(5):24853. 62. Hintze RE, Adler A, Veltzke W. Outcome of mechanical lithotripsy of bile duct stones in an unselected series of 704 patients. Hepatogastroenterology 1996; 43(9):4736. 63. Thomas M, Howell DA, Carr-Locke D, et al. Mechanical lithotripsy of pancreatic and biliary stones: complications and available treatment options collected from expert centers. Am J Gastroenterol 2007;102(9):1896902. 64. Sauter G, Sackmann M, Holl J, et al. Dormia baskets impacted in the bile duct: release by extracorporeal shock-wave lithotripsy. Endoscopy 1995; 27(5):3847.

Management of Bile Duct Stones

273

65. Ranjeev P, Goh K. Retrieval of an impacted Dormia basket and stone in situ using a novel method. Gastrointest Endosc 2000;51(4 Pt 1):5046. 66. Hintze RE, Adler A, Veltzke W, et al. Management of traction wire fracture complicating mechanical basket lithotripsy. Endoscopy 1997;29(9):8835. 67. Maxton DG, Tweedle DE, Martin DF. Retained common bile duct stones after endoscopic sphincterotomy: temporary and longterm treatment with biliary stenting. Gut 1995;36(3):4469. 68. Bergman JJ, Rauws EA, Tijssen JG, et al. Biliary endoprostheses in elderly patients with endoscopically irretrievable common bile duct stones: report on 117 patients. Gastrointest Endosc 1995;42(3):195201. 69. Chopra KB, Peters RA, OToole PA, et al. Randomised study of endoscopic biliary endoprosthesis versus duct clearance for bileduct stones in high-risk patients. Lancet 1996;348(9030):7913. 70. Hui CK, Lai KC, Ng M, et al. Retained common bile duct stones: a comparison between biliary stenting and complete clearance of stones by electrohydraulic lithotripsy. Aliment Pharmacol Ther 2003;17(2):28996. 71. Chan AC, Ng EK, Chung SC, et al. Common bile duct stones become smaller after endoscopic biliary stenting. Endoscopy 1998;30(4):3569. 72. Jain SK, Stein R, Bhuva M, et al. Pigtail stents: an alternative in the treatment of difficult bile duct stones. Gastrointest Endosc 2000;52(4):4903. 73. Horiuchi A, Nakayama Y, Kajiyama M, et al. Biliary stenting in the management of large or multiple common bile duct stones. Gastrointest Endosc 2010;71(7): 12001203.e2. 74. Cerefice M, Sauer B, Javaid M, et al. Complex biliary stones: treatment with removable self-expandable metal stents: a new approach (with videos). Gastrointest Endosc 2011;74(3):5206. 75. Johnson GK, Geenen JE, Venu RP, et al. Treatment of non-extractable common bile duct stones with combination ursodeoxycholic acid plus endoprostheses. Gastrointest Endosc 1993;39(4):52831. 76. Han J, Moon JH, Koo HC, et al. Effect of biliary stenting combined with ursodeoxycholic acid and terpene treatment on retained common bile duct stones in elderly patients: a multicenter study. Am J Gastroenterol 2009;104(10):241821. 77. Katsinelos P, Kountouras J, Paroutoglou G, et al. Combination of endoprostheses and oral ursodeoxycholic acid or placebo in the treatment of difficult to extract common bile duct stones. Dig Liver Dis 2008;40(6):4539. 78. Lee TH, Han JH, Kim HJ, et al. Is the addition of choleretic agents in multiple double-pigtail biliary stents effective for difficult common bile duct stones in elderly patients? A prospective, multicenter study. Gastrointest Endosc 2011; 74(1):96102. 79. Draganov PV, Evans W, Fazel A, et al. Large size balloon dilation of the ampulla after biliary sphincterotomy can facilitate endoscopic extraction of difficult bile duct stones. J Clin Gastroenterol 2009;43(8):7826. 80. Ellis RD, Jenkins AP, Thompson RP, et al. Clearance of refractory bile duct stones with extracorporeal shockwave lithotripsy. Gut 2000;47(5):72831. 81. Amplatz S, Piazzi L, Felder M, et al. Extracorporeal shock wave lithotripsy for clearance of refractory bile duct stones. Dig Liver Dis 2007;39(3):26772. 82. Sackmann M, Holl J, Sauter GH, et al. Extracorporeal shock wave lithotripsy for clearance of bile duct stones resistant to endoscopic extraction. Gastrointest Endosc 2001;53(1):2732. 83. Farrell JJ, Bounds BC, Al-Shalabi S, et al. Single-operator duodenoscopeassisted cholangioscopy is an effective alternative in the management of

274

Buxbaum

84.

85.

86.

87. 88. 89.

90.

91.

92.

93.

94.

95.

96.

97.

98.

99.

100.

choledocholithiasis not removed by conventional methods, including mechanical lithotripsy. Endoscopy 2005;37(6):5427. Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc 2007;65(6):83241. Arya N, Nelles SE, Haber GB, et al. Electrohydraulic lithotripsy in 111 patients: a safe and effective therapy for difficult bile duct stones. Am J Gastroenterol 2004;99(12):23304. Adamek HE, Buttmann A, Wessbecher R, et al. Clinical comparison of extracorporeal piezoelectric lithotripsy (EPL) and intracorporeal electrohydraulic lithotripsy (EHL) in difficult bile duct stones. A prospective randomized trial. Dig Dis Sci 1995;40(6):118592. Cotton PB, Kozarek RA, Schapiro RH, et al. Endoscopic laser lithotripsy of large bile duct stones. Gastroenterology 1990;99(4):112833. Neuhaus H, Hoffmann W, Zillinger C, et al. Laser lithotripsy of difficult bile duct stones under direct visual control. Gut 1993;34(3):41521. Ell C, Hochberger J, May A, et al. Laser lithotripsy of difficult bile duct stones by means of a rhodamine-6G laser and an integrated automatic stone-tissue detection system. Gastrointest Endosc 1993;39(6):75562. Kim HI, Moon JH, Choi HJ, et al. Holmium laser lithotripsy under direct peroral cholangioscopy by using an ultra-slim upper endoscope for patients with retained bile duct stones (with video). Gastrointest Endosc 2011;74(5):112732. Kalaitzakis E, Webster GJ, Oppong KW, et al. Diagnostic and therapeutic utility of single-operator peroral cholangioscopy for indeterminate biliary lesions and bile duct stones. Eur J Gastroenterol Hepatol 2012;24(6):65664. Schreiber F, Gurakuqi GC, Trauner M. Endoscopic intracorporeal laser lithotripsy of difficult common bile duct stones with a stone-recognition pulsed dye laser system. Gastrointest Endosc 1995;42(5):4169. Moon JH, Ko BM, Choi HJ, et al. Direct peroral cholangioscopy using an ultraslim upper endoscope for the treatment of retained bile duct stones. Am J Gastroenterol 2009;104(11):272933. Neuhaus H, Hoffmann W, Gottlieb K, et al. Endoscopic lithotripsy of bile duct stones using a new laser with automatic stone recognition. Gastrointest Endosc 1994;40(6):70815. Neuhaus H, Zillinger C, Born P, et al. Randomized study of intracorporeal laser lithotripsy versus extracorporeal shock-wave lithotripsy for difficult bile duct stones. Gastrointest Endosc 1998;47(5):32734. Jakobs R, Adamek HE, Maier M, et al. Fluoroscopically guided laser lithotripsy versus extracorporeal shock wave lithotripsy for retained bile duct stones: a prospective randomised study. Gut 1997;40(5):67882. Chen YK, Parsi MA, Binmoeller KF, et al. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc 2011;74(4):80514. Disario JA, Freeman ML, Bjorkman DJ, et al. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology 2004;127(5):12919. Bergman JJ, Rauws EA, Fockens P, et al. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones. Lancet 1997;349(9059):11249. Baron TH, Harewood GC. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile

Management of Bile Duct Stones

275

101.

102.

103. 104.

105.

106.

107.

108.

109.

110.

111.

112.

113.

duct stones during ERCP: a metaanalysis of randomized, controlled trials. Am J Gastroenterol 2004;99(8):145560. Park DH, Kim MH, Lee SK, et al. Endoscopic sphincterotomy vs. endoscopic papillary balloon dilation for choledocholithiasis in patients with liver cirrhosis and coagulopathy. Gastrointest Endosc 2004;60(2):1805. Ersoz G, Tekesin O, Ozutemiz AO, et al. Biliary sphincterotomy plus dilation with a large balloon for bile duct stones that are difficult to extract. Gastrointest Endosc 2003;57(2):1569. Maydeo A, Bhandari S. Balloon sphincteroplasty for removing difficult bile duct stones. Endoscopy 2007;39(11):95861. Attasaranya S, Cheon YK, Vittal H, et al. Large-diameter biliary orifice balloon dilation to aid in endoscopic bile duct stone removal: a multicenter series. Gastrointest Endosc 2008;67(7):104652. Stefanidis G, Viazis N, Pleskow D, et al. Large balloon dilation vs. mechanical lithotripsy for the management of large bile duct stones: a prospective randomized study. Am J Gastroenterol 2011;106(2):27885. Itoi T, Itokawa F, Sofuni A, et al. Endoscopic sphincterotomy combined with large balloon dilation can reduce the procedure time and fluoroscopy time for removal of large bile duct stones. Am J Gastroenterol 2009;104(3):5605. Choi CW, Choi JS, Kang DH, et al. Endoscopic papillary large balloon dilation in Billroth II gastrectomy patients with bile duct stones. J Gastroenterol Hepatol 2012;27(2):25660. Itoi T, Sofuni A, Itokawa F, et al. New large-diameter balloon-equipped sphincterotome for removal of large bile duct stones (with videos). Gastrointest Endosc 2010;72(4):82530. Nathanson LK, ORourke NA, Martin IJ, et al. Postoperative ERCP versus laparoscopic choledochotomy for clearance of selected bile duct calculi: a randomized trial. Ann Surg 2005;242(2):18892. Rogers SJ, Cello JP, Horn JK, et al. Prospective randomized trial of LC1LCBDE vs ERCP/S1LC for common bile duct stone disease. Arch Surg 2010;145(1): 2833. Rhodes M, Sussman L, Cohen L, et al. Randomised trial of laparoscopic exploration of common bile duct versus postoperative endoscopic retrograde cholangiography for common bile duct stones. Lancet 1998;351(9097):15961. Lu J, Cheng Y, Xiong XZ, et al. Two-stage vs single-stage management for concomitant gallstones and common bile duct stones. World J Gastroenterol 2012;18(24):315666. Barkun AN, Barkun JS, Fried GM, et al. Useful predictors of bile duct stones in patients undergoing laparoscopic cholecystectomy. McGill Gallstone Treatment Group. Ann Surg 1994;220(1):329.