Twenty-Second versus Sixty-Second Dilation Duration in Endoscopic Papillary Balloon Dilation for the Treatment of Small Common Bile Duct Stones: A Prospective Randomized Controlled Multicenter Trial

BACKGROUND/AIMS Endoscopic papillary balloon dilation (EPBD) has been advocated as an alternative therapy to endoscopic sphincterotomy for the treatment of common bile duct (CBD) stones. However, there is no established consensus on the optimal balloon dilation duration (BDD). We prospectively evaluated the efficacy and post-endoscopic retrograde cholangiopancreatography (ERCP) complications between the 20- and 60-second EPBD groups. METHODS A total of 228 patients with small CBD stones (≤12 mm) were randomly assigned to undergo EPBD with a 20- or 60-second duration at six institutions. We evaluated baseline patient characteristics, endoscopic data, clinical outcomes, and procedure-related complications. In addition, we analyzed risk factors for postprocedural pancreatitis. RESULTS CBD stones were removed successfully in 107 of 109 patients (98.1%) in the 20-second group and in 112 of 119 patients (94.1%) in the 60-second group (p=0.146). Post-ERCP pancreatitis developed in seven patients (6.4%) in the 20-second group and nine patients (7.5%) in the 60-second group (p=0.408). In multivariate analysis, contrast dye injection into the pancreatic duct is a significant risk factor for post-EPBD pancreatitis. CONCLUSIONS Based on the data showing that there were no significant differences in safety and efficacy between the two BDD groups, 20 seconds of BDD may be adequate for treatment of small CBD stones with EPBD.