Tu1964 Randomised Clinical Trial: Should Cholecystectomy Be Needed After Endoscopic Sphincterotomy for Bile-Duct Stones?

Abstract

Background Endoscopic sphincterotomy is regarded as a standard treatment for biliary duct stones. However, it is another issue for the need of additional cholecystectomy after endoscopic sphincterotomy. Especially, unlike Western patients, primary bile duct stones are more prevalent in Korean people. In this study, we compared the treatment strategies of cholecystectomy and gallbladders left in situ. Methods We did a prospective, randomized, single center trial in 90 patients who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to cholecystectomy (n=45) or expectant management (n=45). The primary outcome was further biliary complications. Other outcome measures are included adverse events after cholecystectomy and risk factors of biliary complications. Results Two patients were lost to follow-up immediately in cholecystectomy group. 26 patients (60.5%) in cholecystectomy group and 13 patients (28.9%) in expectant management group underwent cholecystectomy. Median follow-up was 40 months. In intention to treat analysis, 8 patients (18.6%) in the cholecystectomy group returned with further biliary events. Among those with expectant management, 9 (20%) had recurrent biliary events (Breslow, P = 0.349). Adverse events of cholecystectomy (6.9% vs. 4.4%, P = 0.305) and the rate of conversion to open surgery (13.8% vs. 4.4%, P = 1.000) were not different in both groups. In as treated analysis, 4 patients (10.3%) who underwent cholecystectomy and 13 patients (26.5%) who did not undergo cholecystectomy had additional biliary events during follow up period (Log Rank, P = 0.037). However, after excepting the event of cholecystitis, additional biliary events (cholangitis) were not different each other (Log Rank, P = 0.998). Conclusion In this study in Korea, cholecystectomy after endoscopic sphincterotomy for bile duct stones did not reduce additional recurrent cholangitis but additional cholecystitis.