Endoscopic sphincterotomy plus large-balloon dilation versus endoscopic sphincterotomy for removal of bile-duct stones.

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. [ABSTRACT FROM AUTHOR]