Between January 1989 and June 1990, endoscopic sphincterotomy was performed in 308 consecutive patients with common bile duct stones (mean age: 74 years). Complete clearance of common bile duct was achieved at the first attempt in 65% of cases. This rate was significantly related to the size and the number of biliary stones. The success rate reached 97 percent after repeated endoscopic sessions (127 patients), mechanical lithotripsy (20 patients), extracorporeal or intracorporeal lithotripsy (18 and 11 patients, respectively). During the month following the endoscopic sphincterotomy, 39 patients (13%) developed one or more complications and 11 patients (3.7%) died. The complication rate was related to the time elapsed between biliary opacification and endoscopic sphincterotomy (P = 0.04) and between endoscopic sphincterotomy and total common bile duct clearance (P = 0.0007). No patient younger than 75 years died, but death occurred in 4.5% of the patients older than 75 years. Thirty patients (10%) developed endoscopic sphincterotomy-related complications. Cholangitis and bleeding were the most frequent complications (4 and 2%, respectively). Cholangitis occurred more frequently among the patients older than 75 (P < 0.05) or when transhepatic guided endoscopic sphincterotomy or intracorporeal lithotripsy was used (P < 0.005). Cholangitis led to death in 2 patients, 86 and 87 years old (0.7%). Endoscopic sphincterotomy related complications developed within 48 hours in all but 4 patients (2 patients with pancreatitis and 2 patients with cholecystitis).