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.