Jun Heo1, Min Kyu Jung, Chang Min Cho. 1. Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Republic of Korea, hero797@hanmail.net.
Abstract
BACKGROUND:Endoscopic sphincterotomy (EST) is the standard treatment for biliary duct stones. However, performing additional cholecystectomy after EST is controversial. In this study, we aimed to evaluate the effects of cholecystectomy after EST. METHODS:Between December 2008 and July 2011, we performed a prospective, randomized, single-center trial in 90 patients with proven gallstones who underwent EST and stone extraction. After the procedure, patients were randomly allocated to undergo cholecystectomy (n = 45) or to the group of GB left in situ (n = 45). The primary outcome was biliary complications at follow-up. RESULTS:Cholecystectomy was performed in 26 patients (60.5 %) in cholecystectomy group and in 13 patients (28.9 %) in intended conservative group. The median follow-up was 41 months. An intention-to-treat analysis showed that 8 patients (18.6 %) in the cholecystectomy group and 9 (20.0 %) in those who had their GB left in situ had recurrent biliary events (Kaplan-Meier curve, Breslow test, p = 0.555). In an 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 the follow-up period (Log-rank, p = 0.037). However, additional biliary events of cholangitis were similar in the two groups, except for a case of cholecystitis (Log-rank, p = 0.998). CONCLUSIONS:Cholecystectomy after EST for biliary duct stones fails to reduce additional recurrent cholangitis but reduces additional cholecystitis.
RCT Entities:
BACKGROUND: Endoscopic sphincterotomy (EST) is the standard treatment for biliary duct stones. However, performing additional cholecystectomy after EST is controversial. In this study, we aimed to evaluate the effects of cholecystectomy after EST. METHODS: Between December 2008 and July 2011, we performed a prospective, randomized, single-center trial in 90 patients with proven gallstones who underwent EST and stone extraction. After the procedure, patients were randomly allocated to undergo cholecystectomy (n = 45) or to the group of GB left in situ (n = 45). The primary outcome was biliary complications at follow-up. RESULTS: Cholecystectomy was performed in 26 patients (60.5 %) in cholecystectomy group and in 13 patients (28.9 %) in intended conservative group. The median follow-up was 41 months. An intention-to-treat analysis showed that 8 patients (18.6 %) in the cholecystectomy group and 9 (20.0 %) in those who had their GB left in situ had recurrent biliary events (Kaplan-Meier curve, Breslow test, p = 0.555). In an 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 the follow-up period (Log-rank, p = 0.037). However, additional biliary events of cholangitis were similar in the two groups, except for a case of cholecystitis (Log-rank, p = 0.998). CONCLUSIONS: Cholecystectomy after EST for biliary duct stones fails to reduce additional recurrent cholangitis but reduces additional cholecystitis.
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