Endoscopic sphincterotomy was performed in 53 patients with biliary tract disease who were considered to be at high risk from conventional surgical procedures. Forty-five patients had choledocholithiasis, while eight had miscellaneous disorders including carcinoma, stenosis of the papilla, and postoperative biliary fistulae. Forty-three of 45 patients with choledocholithiasis have been free of symptoms since the procedure, and most have had repeat retrograde cholangiography confirming the absence of bile duct-stones. Endoscopic sphincterotomy is a safe and effective procedure in selected high-risk patients, particularly those with choledocholithiasis after cholecystectomy.