Comparison of the Efficacy and Safety of EUS-guided Choledochoduodenostomy and Hepaticogastrostomy for Malignant Distal Biliary Obstruction: A Multicenter, Randomized, Clinical Trial.

OBJECTIVES: Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be performed via two different approaches: choledochoduodenostomy (CDS) and hepaticogastrostomy (HGS). We compared the efficacy and safety of these approaches in malignant distal biliary obstruction (MDBO) patients using a prospective, randomized clinical trial.

METHODS: MDBO patients after failed ERCP were randomly selected for either CDS or HGS. The procedures were performed at nine tertiary centers from September 2013 to March 2016. The primary endpoint was the technical success rate, and the noninferiority of HGS to CDS was examined with a one-sided significance level of 5%, where the noninferiority margin was set at 15%. The secondary endpoints were clinical success, adverse events (AEs), stent patency, survival time, and overall technical success including alternative EUS-BD procedures.

RESULTS: Forty-seven patients (HGS, 24; CDS, 23) were enrolled. The technical success rates were 87.5% and 82.6% in the HGS and CDS groups, respectively, where the lower limit of the 90% confidence interval of the risk difference was -12.2% (P = 0.0278). The clinical success rates were 100% and 94.7% in the HGS and CDS groups, respectively (P = 0.475). The overall AE rate, stent patency, and survival time did not differ between the groups. The overall technical success rates were 100% and 95.7% in the HGS and CDS groups, respectively (P = 0.983).

CONCLUSIONS: This study suggests HGS is not inferior to CDS in terms of technical success. When one procedure is particularly challenging, readily switching to the other could increase technical success. This article is protected by copyright. All rights reserved.