Late complications have been examined in 96 patients consecutively treated for choledocholithiasis by endoscopic sphincterotomy in the years 1976 to 1980. Forty-four of the patients (46%) had the gallbladder in situ. Patients treated for short-term complications--that is, in the 1st month after sphincterotomy--are not included in this study. The mean length of follow-up study was 4.1 years (range, 2 months to 8 years and 9 months). Late bile duct symptoms occurred in seven patients (7%): three (6.8%) in patients with the gallbladder in situ and four (7.6%) in cholecystectomized patients. Stones were found in the common bile duct in three of these patients, one with and two without the gallbladder. The median duration from sphincterotomy to late complication was 8 months (range, 2 months to 5 years). Six of the patients had cholangitis, and the seventh had jaundice with abdominal pain. Two of the patients died of their complications. In conclusion, our results indicate that the frequency of late complications to endoscopic sphincterotomy is low and apparently independent of possible prior cholecystectomy.