GUIDELINE The role of ERCP in benign diseases of the biliary tract This is one of a series of statements discussing the use of is a useful adjunctive technique for the evaluation and GI endoscopy in common clinical situations. The Stan- management of biliary and pancreatic disease. dards of Practice Committee of the American Society for Endoscopists who perform ERCP should have appro- Gastrointestinal Endoscopy (ASGE) prepared this text. In priate training and expertise in this procedure.5,6 Preproce- preparing this guideline, a search of the medical litera- dure coagulation studies are not routinely indicated but ture was performed by using PubMed from January should be considered in select patients, such as those 1980 through December 2013 by using the keyword(s) with a history of coagulopathy or prolonged cholestasis.7 “choledocholithiasis,”“biliary stricture,”“primary scle- Endoscopists should consider correction of coagulopathy rosing cholangitis,”“cholangiopathy,”“sphincter of Oddi if sphincterotomy is anticipated, but specific international dysfunction,”“biliary leak,””choledochal cyst,”“choledo- normalized ratio thresholds for this intervention have not chocele,” AND “gastrointestinal endoscopy,””ERCP,” been established and remain subject to the endoscopist’s “endoscopy,” and “endoscopic procedures.” The search judgment. Antibiotic prophylaxis is indicated in the setting was supplemented by accessing the “related articles” of suspected biliary obstruction with anticipated incomplete feature of PubMed, with articles identified on PubMed drainage (including primary sclerosing cholangitis [PSC]), as the references. Pertinent studies published in English posttransplantation biliary strictures, or ductal leaks.8 were reviewed. Additional references were obtained Temporary pancreatic duct stenting and rectal indo- from the bibliographies of the identified articles and methacin lower both the risk and severity of post-ERCP from recommendations of expert consultants. When little pancreatitis in high-risk populations, such as those under- or no data exist from well-designed prospective trials, going precut biliary sphincterotomy or difficult biliary can- emphasis is given to results from large series and reports nulation or with clinical suspicion of sphincter of Oddi from recognized experts. Guidelines for appropriate use dysfunction (SOD), a history of post-ERCP pancreatitis, of endoscopy are based on a critical review of the avail- pancreatic sphincterotomy, pneumatic dilation of an intact able data and expert consensus at the time the guidelines biliary sphincter, and ampullectomy.9,10 Although rectal are drafted. Further controlled clinical studies may be indomethacin alone appeared to be more effective for pre- needed to clarify aspects of this guideline. This guideline venting post-ERCP pancreatitis in these high-risk patients may be revised as necessary to account for changes in than both pancreatic stent placement alone and the combi- technology, new data, or other aspects of clinical prac- nation of indomethacin and pancreatic stent placement, a tice. The recommendations were based on reviewed randomized, controlled trial comparing rectal indomethacin studies and were graded on the strength of the supporting alone with indomethacin with pancreatic stent is needed.11 evidence using the GRADE criteria1 (Table 1). BENIGN BILIARY TRACT DISEASE INTRODUCTION ERCP is particularly useful in the management of pa- ERCP was first reported in 1968 and was quickly tients with biliary obstruction due to choledocholithiasis accepted as a safe, direct technique for evaluating pancrea- and other benign diseases of the biliary tract such as biliary ticobiliary disease.2 With the introduction of endoscopic strictures and postoperative biliary leaks. Successful endo- sphincterotomy in 1974, therapeutic pancreaticobiliary scopic cholangiography with relief of biliary obstruction endoscopy was developed.3,4 Over the past several de- should be technically achievable in more than 90% of pa- cades, ERCP has evolved from a diagnostic procedure to tients.5 Adjunctive cholangioscopy at the time of ERCP one that is almost exclusively therapeutic. Other imaging can be helpful in the management and treatment of chol- techniques, such as abdominal US, CT, MRCP, EUS, and in- edocholithiasis and for assessing indeterminate stric- traoperative cholangiography, provide diagnostic informa- tures.12 ERCP with bile duct stenting and/or biliary tion that allows appropriate selection of patients for sphincterotomy is the preferred treatment strategy for therapeutic ERCP.5 ERCP with cholangiopancreatoscopy bile leaks.13-16 Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy Choledocholithiasis 0016-5107/$36.00 The most common cause of biliary obstruction is chole- http://dx.doi.org/10.1016/j.gie.2014.11.019 docholithiasis. Patients may present with biliary colic, www.giejournal.org Volume 81, No. 4 : 2015 GASTROINTESTINAL ENDOSCOPY 795 The role of ERCP in benign diseases of the biliary tract rate of less than 1% in expert hands.24 These results 29 TABLE 1. GRADE system for rating the quality of compare favorably with those of most surgical series. In evidence for guidelines1 cases of failed primary biliary cannulation, precut (eg, nee- dle knife) sphincterotomy or a combined percutaneous/ Quality of endoscopic approach may be necessary. The adverse event evidence Definition Symbol rates associated with these techniques are higher than for 4444 High quality Further research is very unlikely standard extraction techniques, reflecting greater technical to change our confidence in the fi 30 estimate of effect dif culty. EUS-guided biliary access by highly experi- enced practitioners has also become a viable alternative 444B Moderate Further research is likely to have in cases of failed primary biliary cannulation.31,32 Concern quality an important impact on our confidence in the estimate of for post-ERCP pancreatitis and mortality has led many en- effect and may change the doscopists to limit biliary sphincteroplasty without biliary estimate sphincterotomy to patients with persistent coagulopathy 33-39 44BB and Billroth II anatomy. However, endoscopic papillary Low quality Further research is very likely to R have an important impact on large-balloon ( 12 mm) dilation combined with sphincter- our confidence in the estimate otomy can result in high success rates for complete clear- of effect and is likely to change ance of large and difficult choledocholithiasis with a low the estimate rate (2.3%) of post-ERCP pancreatitis.40-43 Very low Any estimate of effect is very 4BBB Stone removal is usually accomplished with balloon quality uncertain extractor catheters or wire baskets. Occasionally, large or fi Adapted from Guyatt et al.1 impacted stones may be dif cult to remove. Fragmentation of large stones and the management of impacted baskets with entrapped stones can be facilitated by the perfor- mance of mechanical lithotripsy or cholangioscopy with obstructive jaundice, cholangitis, or pancreatitis. Although electrohydraulic or laser lithotripsy.44-46 If stone removal the sensitivity and specificity of ERCP for detecting com- is unsuccessful, biliary decompression should be accom- mon bile duct stones are more than 95%, small stones plished by placement of a stent or nasobiliary drain, may be missed.5 Studies of cholangiography alone for when feasible.47 the detection of stones have reported a false-negative Peroral cholangioscopy with intraductal lithotripsy has rate as high as 13%.17-21 Careful injection of contrast and been demonstrated to clear difficult extrahepatic biliary early radiographs may help detect stones and avoid over- stones in 83% to 100% of patients.48-51 Among patients filling of the ducts or proximal advancement of stones with intrahepatic bile duct stones, intraductal lithotripsy into the intrahepatic ducts. The introduction of air bubbles combined with extracorporeal shock wave lithotripsy may into the biliary ductal system by the contrast injection cath- successfully clear stones in approximately two-thirds of pa- eter can lead to a misdiagnosis of stones. tients.52 Methods for cholangioscopically guided intraduc- If choledocholithiasis is found at the time of laparo- tal lithotripsy include electrohydraulic lithotripsy and scopic cholecystectomy and not cleared with common pulsed laser lithotripsy.53,54 Pulsed laser lithotripsy allows duct exploration, ERCP and stone extraction can be per- for more precise targeting, thereby reducing the risk of formed after surgery.22,23 ERCP with biliary decompression bile duct injury. However, its relatively high equipment is the procedure of choice for the treatment of acute cost has limited its widespread use. cholangitis that accompanies acute biliary pancreatitis Endoscopic sphincterotomy and stone extraction (ABP).24-27 A recent Cochrane review evaluated outcomes without subsequent cholecystectomy may be appropriate with early ERCP in patients with ABP compared with con- in select patients with comorbid conditions that increase servative management with or without selective ERCP. their surgical risk.4 However, biliary symptoms recur twice This review found that in patients without concomitant as commonly in patients whose gallbladder remains in situ cholangitis or biliary obstruction, there is no advantage with a 5-year risk of significant biliary adverse events lead- of early ERCP with regard to mortality and local or systemic ing to cholecystectomy as high as 15%.5,55,56 adverse