Background and Study Aims: There have been growing concerns about the long-term sequelae of endoscopic sphincterotomy (ES). The aims of the study were to evaluate the long-term clinical outcome of ES for choledocholithiasis and to identify the predictors of recurrence. Patients and Methods: A total of 529 patients (233 men, 296 women; mean age 63, range 9-88) who underwent successful ES for choledocholithiasis were evaluated. Follow-up data were obtained retrospectively. Statistical analyses were carried out for 334 patients who had a follow-up of at least 5 years or had recurrence. Results: Immediate complications occurred in 37 patients (7%). Follow-up data were available in 458 patients (86.6%), of whom 280 (61.1%) were asymptomatic, 127 (27.7%) died from unrelated causes without recurrence, and 51 (11.1%) had biliary symptoms and/or choledocholithiasis recurrence. Most recurrences (65%) occurred more than 2 years following ES and were observed on multiple occasions in 13 patients (2.8%). A bile duct diameter of 22 mm or greater was found to predict recurrence. Of 190 patients with an intact gallbladder, 11 (5.8%) developed acute cholecystitis necessitating emergency cholecystectomy; all of these had previously documented gallstones. Conclusions: Endoscopic sphincterotomy for choledocholithiasis is found to be safe at long-term follow-up. A dilated bile duct ( ! 22 mm) is a marker for patients at increased risk of recurrence of symptoms and/or choledocholithiasis.