Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos)

Background and Aims: Studies on EUS-guided transmural biliary drainage (EUS-BD) have evaluated its efficacy as a rescue technique after failed ERCP. We performed a single-center, single-blind, randomized trial to compare EUS-BD and ERCP as primary treatment for distal biliary obstruction in pancreatic cancer. Methods: Patients underwent EUS-BD (n = 33) or ERCP (n = 34). The primary endpoint was the rate of adverse events. Secondary endpoints were technical success, treatment success (defined as decline in serum bilirubin by 50% at a 2-week follow-up), reinterventions, and intraoperative technical outcome, when applicable. Follow-up was until death or a minimum of 6 months. Results: The rates of adverse events were 21.2% (6.1% moderate severity; others mild severity) in the EUS-BD group and 14.7% (5.9% moderate severity; others mild severity) in the ERCP group (risk ratio, .69; 95% confidence interval, .24-1.97; P = 49). There were no procedure-related deaths. There was no significant difference in the rates of technical success (90.9% vs 94.1%, P = .67), treatment success (97% vs 91.2%, P = .61), or reinterventions (3.0% vs 2.9%, P = .99) between EUS-BD and ERCP cohorts, respectively. The endoscopic interventions did not impede subsequent pancreaticoduodenectomy that was performed in 5 of 33 patients (15.2%) in the EUS-BD and 5 of 34 patients (14.7%) in the ERCP group (P = .99). Conclusions: Given the similar rates of adverse events and treatment outcomes in this randomized trial, EUS-BD is a practical alternative to ERCP for primary biliary decompression in pancreatic cancer. (Clinical trial registration number: NCT03054987.)