Background and study aims: Endoscopic balloon sphincteroplasty (EBS) has been reported to be a safe alternative to sphincterotomy for the treatment of bile duct stones. We evaluated the factors which influence the therapeutic efficacy of EBS.
Patients and methods: A total of 118 consecutive patients with bile duct stones were treated by EBS. After conventional endoscopic retrograde cholangiography (ERC), EBS was done using a biliary dilation catheter (balloon diameter, 8mm). The duct was then cleared using Dormia baskets or retrievel balloon catheters. When the stones were greater than 8 mm in diameter, mechanical lithotripsy was performed before extraction. Complete stone clearance was assessed by balloon-ERC and intraductal ultrasonography. Therapeutic efficacy was assessed using univariate and multivariate analysis. Patients were classified into three groups according to the bile duct diameter: nondilated (bile duct < or = 10 mm), mildly dilated (10 mm < bile duct < or = 15 mm), and severely dilated group (bile duct > 15 mm).
Results: In 113 of 118 (96%) patients, the stones were completely cleared with one to six endoscopic sessions (mean 1.6 sessions). In the nondilated group, 24 of 28 (85%) patients were cleared of stones in one session (mean 1.2 sessions), without the use of mechanical lithotripsy in 23 of 28 (82 %) patients. In the mildly dilated group, 23 of 38 (61 %) patients were cleared of stones in one session (mean 1.5 sessions). In contrast, in the severely dilated group, only 16 of 52 (31 %) patients were cleared of stones in one session (mean 2.0 sessions). Stone size, number of stones, and use of mechanical lithotripsy were independent variables which influenced the success of stone clearance in one session after EBS.
Conclusion: When EBS is done in patients with bile duct stones, bile duct diameter may be a good indicator of therapeutic efficacy. In patients with severely dilated bile ducts (> 15 mm), EBS is of limited effectiveness.