Abstract

BackgroundThe Calgary Bile Leak Rule was developed to identify patients in whom biliary stent removal via gastroscopy could be safely performed in lieu of ERCP for post-surgical bile leaks.AimsThis study aimed to evaluate a Modified Calgary Bile Leak Rule (MCBLR) for a cohort of patients who underwent laparoscopic cholecystectomy complicated by bile leak.MethodsThis retrospective cohort study included patients who underwent ERCP for management of laparoscopic cholecystectomy-induced bile leaks between 2005 and 2017. The primary outcome was defined as the absence of persisting bile leak or other pathology on follow-up ERCP. The MCBLR includes a) normal post-surgical serum alkaline phosphatase, b) small or absent leak with no other biliary pathology on initial ERCP, and c) time between initial and follow-up ERCP was 4–8 weeks. Test performance of the prediction rule was analyzed by calculating sensitivity, specificity, positive predictive value and negative predictive value.Results124 cases met inclusion criteria, of which 116 (94%) of bile leak cases had no leak identified during the follow-up ERCP. 8 (6.4%) had a persisting bile leak on follow-up ERCP. Bivariate analysis found no factors significantly associated with the primary outcome. The MCBLR demonstrated a sensitivity of 100% (95% CI 63% - 100%), a specificity of 35% (95% CI 26% - 44%), a positive predictive value of 10% (95% CI 4% - 18%), and a negative predictive value of 100.0% (91% to 100%).ConclusionsThe MCBLR demonstrated high sensitivity and negative predictive value for determining the need for repeat ERCP following endoscopic management of laparoscopic cholecystectomy-induced bile leaks.Funding AgenciesNone

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