Efficacy and safety of three methods of endoscopic retrograde cholangiopancreatography in removing small common bile duct stones: a prospective multicenter randomized controlled study

Abstract

Background: In endoscopic retrograde cholangiopancreatography (ERCP), common bile duct stones (CBDSs) can be removed through strategies, including endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (ESBD). By comparing the efficacy and safety of these three methods, we aimed to determine the optimal technique for the removal of small CBDSs (≤ 10 mm in size).

Methods: This was a multicenter, prospective, parallel controlled study involving patients with small CBDSs undergoing ERCP in three tertiary medical institutions in Jiangsu Province, China, who were randomly divided into the EST group, EPBD group, and ESBD group. The efficiencies of these three techniques were compared by analyzing the first-session and overall success rates of stone removal and the use of endoscopic mechanical lithotripsy (EML). Their safety was compared by measuring the incidences of post-ERCP pancreatitis (PEP) and other adverse events.

Results: A total of 350 patients were enrolled. Eligible patients were randomly assigned to the EST group (n = 116), EPBD group (n = 118), and ESBD group (n = 116). Sex, median age, number, and median size of small CBDSs were comparable. The first-session (all > 97%) and overall success rates of stone removal (all 100%) were high. No significant difference was detected in the incidence of EML (all < 1%). The incidences of PEP (all < 6%), bleeding, perforation, infection, and hyperamylasemia were low in all three groups, with no significant among-group differences.

Conclusion: EST, EPBD, and ESBD all exhibit excellent efficacy and safety in the removal of small CBDSs. EPBD is recommended as the optimal method for removing small CBDSs due to its simple procedures, functional preservation of the sphincter of Oddi, and fewer long-term complications.

Keywords: Endoscopic papillary balloon dilatation; Endoscopic sphincterotomy; Endoscopic sphincterotomy plus balloon dilatation; Post-ERCP pancreatitis; Small common bile duct stone.