Consensus Statement Management of the Biliary Tract in Acute Necrotizing Pancreatitis The BAT,

AGE, ASGE Consensus Panel*

Questions Addressed by the Consensus Panel 1. What are the clinical, biochemical,

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and radiologic criteria for the diagnosis of biliary pancreatitis in patients with acute necrotizing pancreatitis (ANP)? What is the optimal method for biliary tract imaging in ANP? When is early endoscopic retrograde cholangiopancreatography (ERCP) indicated in ANP? Should sphincterotomy be performed if no stone is seen? What is the optimal timing for cholecystectomy in ANP? Is cholecystectomy necessary in patients who already have undergone endoscopic sphincterotomy? What is the appropriate operative approach to the gallbladder and bile duct in patients with ANP? Given the present state of the art, what clinical trials could be designed now that would most effectively address this clinical problem?

General Summary The incidence of biliary pancreatitis parallels that of gallstone disease, and is more common in women between the ages of 50 and 70. Patients with biliary pancreatitis are as likely as those with pancreatitis of other etiologies to develop severe disease. Mortality from acute biliary pancreatitis (as determined from the placebo arm of treatment studies) averages approximately 6%. Passage or impaction of a stone is generally accepted as an event common to all patients with gallstone pancreatitis. The precise mechanism whereby this phenomenon leads to pancreatitis and the factors determining whether an attack will be mild or severe remain largely unknown.

1. Differentiation of biliary from other forms of pancreatitis is based on a combination of serum tests and imaging. Abnormalities in liver function tests, in particular a threefold elevation of alanine aminotransferase (AI-T), are very specific for the diagnosis. Ultrasound will detect gallstones in 70% to 80% of those with acute biliary pancreatitis. The combination of both tests is highly accurate for the diagnosis of acute biliary pancreatitis. 2. Data are insufficient to define the optimal method for biliary tract imaging in ANI? ERCP has been the “gold standard” and also has therapeutic potential. However, it is an invasive test with a high cost and potentially serious complications, especially in patients with pancreatitis. Ultrasound remains the test of choice for detection of cholelithiasis and bile duct dilatation, but has a very low sensitivity for common bile duct stones. Magnetic resonance cholangiopancreatography (MRCP) has now become more widely available and has a sensitivity of more than 90% for choledocholithiasis, and CT cholangiography is an emerging alternative that may prove to be equally useful. However, the utility of these tests has not been validated in the setting of acute pancreatitis, and their applicability in patients with severe pancreatitis is not clear. Many prospective studies, using ERCP or intraoperative cholangiography as the gold standard, have shown that endoscopic ultrasound (EUS) is extremely accurate for the detection of choledocholithiasis. Most studies show sensitivity of more than 90% and specificity of 95% to 100%. However, evidence of similar accuracy in the setting of acute pancreatitis is limited.

Correspondence: Carlos Fernbdez-de1 Castillo, M.D., Department of Surgery, Massachusetts MA02114. YThe Society for Surgery of the Alimentary Tract, American Gastroenterological Association, Endoscopy.

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Although complication rates are very low, EUS should still be considered an invasive test. 3. Early ERCP with sphincterotomy and stone extraction is indicated for patients with pancreatitis and concomitant cholangitis or significant persistent biliary obstruction (usually serum bilirubin >5 mg/dl). Achieving adequate biliary drainage following the procedure is paramount, and therefore ERCP should be attempted only in settings where appropriate expertise is available. Evidence to support the use of ERCP in severe biliary pancreatitis without biliary sepsis or obstruction is conflicting. There are no data to support or refute the use of sphincterotomy if, at the time of ERCP done for suspected biliary pancreatitis, no stone is found. ERCP should not be performed acutely in patients with predicted mild pancreatitis of suspected or proven biliary etiology in the absence of biliary obstruction. 4. In general, patients with biliary pancreatitis should undergo cholecystectomy during their initial hospitalization to prevent recurrent pancreatitis or other biliary complications. Exceptions include elderly patients with high surgical risk in whom ERCP and endoscopic sphincterotomy may suffice. Other situations where delaying cholecystectomy may be advisable are in patients with necrotizing pancreatitis in whom inflammatory changes may need to subside to allow for a safer operation. There is no indication for routine preoperative ERCP in patients with gallstone pancreatitis who will undergo cholecystectomy. MRCP, EUS, and CT cholangiography all have a potential role in the preoperative assessment of these

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patients, but there is insufficient evidence to support or refute their use on a routine basis. laparoscopic cholecys5. Barring contraindications, tectomy is the procedure of choice for removal of the gallbladder in patients with biliary pancreatitis. Recent ERCP, MRCP, or EUS will usually have ruled out choledocholithiasis, but if not, intraoperative cholangiography or intraoperative ultrasonography should be performed in all of these patients. If a stone or stones are found at the time of surgery, the following options are available: transcystic laparoscopic removal, laparoscopic choledochotomy, endoscopic antegrade sphincterotomy, conversion to an open common bile duct exploration, or planned postoperative ERCP and endoscopic sphincterotomy. Data are insufficient to provide for a consensus regarding optimal management.

Areas for Future Clinical Investigation 6. Given the legitimate controversy regarding the indications for ERCP in acute pancreatitis in the absence of biliary obstruction, a randomized trial of ERCP with or without sphincterotomy early in the course of predicted severe biliary pancreatitis is needed. Future clinical trials should address the role of MRCP, EUS, and CT cholangiography in the evaluation of patients with biliary pancreatitis, both early in the course of the disease (to confirm the etiology of the pancreatitis and to detect the presence of persistent choledocholithiasis) and as part of the precholecystectomy workup.

Panel were:

Gregory BulkIey, M.D., Johns Hopkins Medical Institutions, Baltimore, Md.; David L. Carr-Locke, M.D., Brigham and Women’s Hospital, Boston, Mass.; Eugene I? DiMagno, M.D., Mayo Clinic, Rochester, Minn.; Carlos Femlndez-de1 Castillo, M.D., Massachusetts General Hospital, Boston, Mass.; Aaron S. Fink, M.D., Atlanta Veterans Administration Medical Center, Decatur, Ga.; W. Scott Helton, M.D., University of Illinois, Chicago, Ill.; Keith Lillemoe, M.D., Johns Hopkins Medical Institutions, Baltimore, Md.; Keith Lindor, M.D., Mayo Clinic, Rochester, Minn.