Background and study aims: To assess the safety and feasibility of EUS-guided choledochoduodenostomy (EUS-CDS) using lumen-apposing metal stents (LAMS) as primary drainage strategy in patients with distal malignant biliary obstruction (MBO).
Patients and methods: Prospective single center pilot study in patients with a pathology confirmed MBO without gastric-outlet obstruction. Primary outcome was technical success. Secondary outcomes included clinical success, adverse events (AEs) and re-interventions. The study was registered in the Netherlands Trial Registry (registry number NL9757).
Results: Overall, 22 patients were enrolled (median age 69.5 years [IQR 64-75.2]. Technical success was achieved in 20/22 patients (91%). Adverse events occurred in one patient, namely a perforation occurred due to inadequate deployment (5%), treated in the same procedure. Clinical success was achieved in 19/22 patients (86%). Stent dysfunction was observed in 11 of the 20 patients after technically successful EUS-CDS (55%). Two patients were treated conservatively, in 9 patients re-intervention(s) were performed. One patient died <30 days due to fulminant disease progression.
Conclusions: This study confirms safety and feasibility of EUS-CDS using LAMS as the primary drainage strategy. The high incidence of stent dysfunction should be improved before EUS-CDS with LAMS can be seen as a valid alternative to ERCP.