Background: Endoscopic sphincterotomy (EST) to remove bile-duct stones is the most frequently used endoscopic technique. Few reports exist regarding application of large-balloon dilation (LBD) after EST for treatment of patients with bile-duct stones.

Objective: To compare the effect of EST plus LBD with that of EST alone.

Design: A prospective randomized controlled trial.

Setting: A large tertiary-referral center.

Patients and interventions: Two hundred consecutive patients with bile-duct stones were randomized in equal numbers to EST plus LBD (12- to 20-mm balloon diameter) or EST alone.

Main outcome measurements: Successful stone removal and complications such as pancreatitis and bleeding.

Results: EST plus LBD compared with EST alone resulted in similar outcomes in terms of overall successful stone removal (97.0% vs 98.0%), large size (>15 mm) stone removal (94.4% vs 96.7%), and the use of mechanical lithotripsy (8.0% vs 9.0%). Complications were similar between the 2 groups (5.0% vs 7.0%, P = .767). Complications were as follows for the EST plus LBD group and the EST group: pancreatitis, 4.0% and 4.0%; cholecystitis, 1.0% and 1.0%; and bleeding (delayed), 0% and 2.0%, respectively.

Conclusions: Based on the similar rates of successful stone removal and complications, EST plus LBD should be an effective alternative to EST. EST plus LBD is a safe and effective treatment for endoscopic removal of common bile duct stones.