OBJECTIVE: Endoscopic sphincterotomy (ES) reduces sphincter function, which may allow reflux of pancreatic juice and intestinal contents into the common bile duct. The reflux, if present, may cause development of biliary tract carcinomas, as may anomalous pancreaticobiliary junction. We prospectively investigated pancreatobiliary and duodenobiliary reflux after ES. METHODS: In 15 patients with choledocholithiasis, ductal bile was sampled for amylase concentration and bacterial culture during endoscopic retrograde cholangiopancreatography, before and at 7 days to 5 yr after ES. To provide comparative data, ductal bile was sampled in II patients with gallbladder cholesterol polyps or anomalous pancreaticobiliary junction who did not undergo ES. RESULTS: Amylase concentration of ductal bile in patients with choledocholithiasis before ES was not different from that in patients with gallbladder polyps. Its concentration was increased 7 days after ES compared with that before ES, reaching the level of that in patients with anomalous pancreaticobiliary junction. Thereafter, amylase concentration gradually decreased, returning to that before ES by 1 yr. After ES, bactobilia occurred in 60-80% of patients, although none developed acute cholangitis. CONCLUSIONS: Although ES causes transient pancreatobiliary reflux, the reflux is abolished by 1 yr after ES. ES is unlikely to increase the risk for development of biliary tract carcinoma as long as cholangitis or bile duct stones do not recur. (Am J Gastroenterol 1999;94:795-798. (C) 1999 by Am. Coll. of Gastroenterology).