Endoscopic Ultrasound-Guided Biliary Drainage Versus Ercp in Inoperable Malignant High-Grade Distal Bile Duct Obstruction: A Randomized Study; Preliminary Analysis

Objective: To compare the efficacy and safety of Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) and Endoscopic retrograde cholangiopancreatography (ERCP) for biliary drainage of high-grade malignant distal bile duct obstruction (HGMDBO).Material and Methods: Patients with inoperable HGMDBO were randomized to undergo either: EUS-CDS or ERCP. HGMDBO was defined as total bilirubin ≥15 mg/dl and/or a common bile duct size ≥12 mm. The other procedure was performed if the utilized surgery failed: success rates, procedure time and complication rates were assessed.Results: Preliminary analysis included 10 patients (5 per group); from August 2018 to January 2019, whose demographic data were similar. Technical success rates were at 60% (3/5) vs. 80% (4/5) for EUS-CDS and ERCP, respectively. Clinical success rates were at 80% (4/5) for both. The mean (S.D.) procedure times were 33.72 (14.5) and 45.22 (26.74) min for EUS-CDS and ERCP, respectively, without any significant difference (p-value=0.498). Adverse events in the EUS-CDS group included one case of mild biliary peritonitis and one case of post-sphincterotomy bleeding, while the ERCP group included one case of cholangitis with liver abscess and one case of mild bleeding.Conclusion: Preliminary data showed similar technical and clinical success rates. EUS-CDS had a shorter mean procedure time than that of ERCP; however, statistical significance was not reached. Further comprehensive studies are needed to validate the role of EUS-CDS as a primary drainage procedure.