Clinical efficacy, timing, and outcomes of ERCP for management of bile duct leaks: a nationwide cohort study.

Endoscopic retrograde cholangiopancreatography (ERCP) can safely and effectively manage postsurgical or traumatic bile duct leaks (BDLs). Standardized guidelines are lacking regarding effective management of BDLs. Our aim was to evaluate the efficacy, clinical outcomes, and complications of different ERCP techniques and intervention timing using a nationwide database.  We performed a retrospective analysis of the IBM Explorys database (1999-2019), a pooled, national, de-identified clinical database of over 64 million unique patients across the United States. ERCP timing after BDL was classified as emergent (< 1 day), urgent (1-3 days) or expectant (> 3 days). ERCP technique was classified into sphincterotomy, stent or combination therapy. ERCP complications were defined as pancreatitis, duodenal perforation, duodenal hemorrhage, and ascending cholangitis within 7 days of the procedure.  Expectant ERCP had a decreased risk of adverse events (AEs) compared to emergent and urgent ERCP (  = 0.004). Rehospitalization rates also were lower in expectant ERCP (  < 0.001). Patients with COPD were more likely to have an AE if the ERCP was performed emergently compared to expectantly (  = 0.002). Combination therapy had a lower rate of ERCP failure compared to placement of a biliary stent (  = 0.02). There was no statistically significant difference in rates of ERCP failure between biliary stent and sphincterotomy (  = 0.06) or sphincterotomy and combination therapy (  = 0.74).  Our study suggests that ERCP does not need to be performed emergently or urgently for management of BDLs. Combination therapy is superior to stenting or sphincterotomy; however, future prospective studies are needed to validate these findings.