Lumen-apposing metal stents with or without pigtail stent for endoscopic ultrasound-guided biliary drainage of malignant obstruction: an open-label multicentre randomised trial (BAMPI Trial)

Aims 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. 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 14 days), adverse events (AEs), and others ([Table 1]).

Table 1  

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 [1] [2] [3].

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.

Publikationsverlauf

Artikel online veröffentlicht:
14. April 2023

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• 3 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