Percutaneous transhepatic biliary drainage versus endoscopic ultrasound-guided biliary drainage with primary metal stenting for unresectable malignant distal biliary obstruction

Background: Unresectable malignant distal biliary obstruction (MDBO) may be treated with endoscopic ultrasound-guided (EUS-BD) or percutaneous transhepatic (PTBD) biliary drainage if endoscopic retrograde cholangiopancreatography fails or is not feasible. This study compared EUS-BD and PTBD using an improved ultrasound-guided method with primary metal stenting. Methods: A prospective, longitudinal (follow-up 6 months), nonrandomized, noninferiority (10% margin) trial was conducted. Patients were assigned to centers with high competence in one of the two techniques. The primary end point was technical success, with propensity score matching employed to balance differences. Differences in secondary end points were evaluated with two-sided superiority analyses. Results: 209 patients (mean age 73 years) were enrolled between December 2018 and August 2024 from 14 European centers and were subsequently matched 1:1. Noninferiority of PTBD vs. EUS-BD could not be demonstrated with regard to technical success (91.2% vs. 97.1%; P = 0.17; 95%CI -2.3% to 15.1%). Clinical success (intention-to-treat: 73.5% vs. 55.9%; P = 0.05), procedure time, length of hospital stay, and rate of biliary reintervention within 30 days (0.03 vs. 0.31; P < 0.001) were significantly better in the EUS-BD cohort, driven mainly by EUS-guided choledochoduodenostomy (EUS-CDS). No significant differences were observed in adverse events (grades 1-4) (16.7% vs. 14.5%; P = 0.82), pain score, clinical success (per-protocol), rate of biliary reinterventions within 6 months, or overall survival. Conclusions: EUS-BD, particularly EU-CDS, might be preferred over PTBD in unresectable MDBO owing to better clinical success and a lower biliary reintervention rate.