LUMEN-APOSSING METAL STENTS WITH OR WITHOUT PIGTAIL STENT IN ENDOSCOPIC ULTRASOUND-GUIDED BILIARY DRAINAGE FOR MALIGNANT OBSTRUCTION: AN OPEN-LABEL MULTICENTER RANDOMIZED TRIAL (BAMPI STUDY)

Introduction: It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency.
Objective: The aim is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (CDS-type) for the management of distal malignant biliary obstruction.
Methods: This is a multicentre, open-label, randomised controlled trial with two parallel groups. The primary endpoint was the rate of recurrent biliary obstruction (RBO), as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin >50% within 14days), adverse events, and others.
Results: Between November-2020 and October-2022, 123 patients were screened and 84 with malignant biliary obstruction, and underwent EUS-CDS, were randomised: 44 patients in LAMS group and 40 in LAMS-DPS group. The rate of RBO (31.8 vs12.5%; OR 3.26[IC95% 1.05–10.12], p=0.04) was higher in LAMS group, and procedure time (30 vs 20-min, p=0.02) in DPS-group. Although, more biliary reinterventions (22.7 vs 12.5%, p=0.26) and longer time-to-RBO (51.5 vs 155.5days, p=0.10) were encountered in LAMS group, it was non-significant. AEs were higher in DPS-group (4.5 vs20%, p=0.04). No differences between technical (88 vs 97%) and clinical success (88 vs 92%). NCT04595058 ClinicalTrials.gov.
Conclusions: This trial confirms that CDS with LAMS is an effective technique. The technical strategy of placing a pigtail within the LAMS is associated with a lower risk of RBO, but longer procedure time and related-AEs.

Reference: Garcia-Sumalla A, Loras C, Sanchiz V, et al. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials. 2022; 23: 181.