A Preliminary Comparison of Endoscopic Sphincterotomy, Endoscopic Papillary Large Balloon Dilation, and Combination of the Two in Endoscopic Choledocholithiasis Treatment

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/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.