Abstract
BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones. Endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilation (EPLBD), and endoscopic sphincterotomy plus large balloon dilation (ESLBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones. MATERIAL AND METHODS: Between July 2011 and December 2013, 255 consecutive patients with proven CBD stones were randomly assigned to EST, EPLBD, or ESLBD (n=85/group). The stone clearance rate, cannulation time, procedural time, frequency of mechanical lithotripsy (ML) use, complications, mortality, and procedural costs were compared. RESULTS: A total of 92.9%, 91.8%, and 96.5% of the patients in the EST, EPBD, and ESBD groups had stones cleared at first ERCP (P=0.519), respectively. ML was used in 9.4%, 14.1%, and 8.2% of the patients in the EST, EPLBD, and ESLBD groups (P=0.419). The costs of EPLBD were higher than EST and lower than ESLBD (P<0.001). Complications occurred in 4.7%, 4.7%, and 5.9% of the patients in the EST, EPLBD, and ESLBD groups, respectively (P=1.000). The proportion in severity was similar (P=0.693). None of the patients died after the procedures. The rates of the post-ERCP pancreatitis, cholangitis, and bleeding were similar among all groups. CONCLUSIONS: EST, EPLBD, and ESLBD might clear CBD stones with equal efficacy and safety. A non-inferiority trial might be necessary to confirm these results.