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 biliary drainage (PTBD) procedures if ERCP fails or is not feasible. The aim of this study was to compare EUS-BD and PTBD using an improved ultrasound-guided method with primary metal stenting. METHODS: A prospective, longitudinal (follow-up of 6 months), non-randomized, non-inferiority trial (10% margin) was conducted. Patients were assigned to centres with high competence in one of the two techniques. Technical success was the primary endpoint, with propensity score matching (PSM) employed to balance differences. Differences in secondary endpoints were evaluated with two-sided superiority analyses. RESULTS: A total of 209 patients (mean age: 73 years) were enrolled between December 2018 and August 2024 from 14 centres in Europe and were subsequently matched 1:1. Non-inferiority 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 re-intervention within 30 days (0.03 vs 0.31, p < 0.001) were significantly better in the EUS-BD cohort, mainly driven by EUS-guided choledochoduodenostomy. No significant differences were observed in the rate of adverse events (grades I-IV) (16.2% vs 14.5%, p = 0.82), pain score, clinical success (per-protocol), rate of biliary re-interventions within six months, or overall survival. Conclusions EUS-BD, particularly EU-CDS, might be preferred over PTBD in unresectable MDBO in terms of better clinical success and lower biliary re-intervention rate.