Lumen-Apposing Stents With or Without Pigtail in Endosonography-Guided Biliary Drainage for Malignant Distal Biliary Obstruction.

[BACKGROUND & AIMS] Endoscopic ultrasound-guided biliary drainage, creating a choledochoduodenostomy and using lumen-apposing metal stents (LAMSs), is a promising intervention for the management of malignant distal biliary obstruction (MDBO). But concerns exist regarding its stent patency. Our aim was to determine whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through LAMS offered a clinical benefit by improving the stent dysfunction rate.

[METHODS] This multicenter randomized controlled trial was carried out in 7 tertiary hospitals. Patients with MDBO secondary to resectable, locally advanced, or unresectable cancers, and indication for biliary drainage, were eligible for inclusion. Patients were randomly assigned (1:1) to either the LAMS group or the LAMS-DPS group. The primary endpoint was the rate of recurrent biliary obstruction (RBO), detected during follow-up. The secondary endpoints were technical and clinical success, safety, time to RBO, reinterventions, and hospitalization.

[RESULTS] Between November 2020 and October 2022, we screened 123 patients with MDBO, of whom 91 were randomly assigned to LAMS (n = 47) or LAMS-DPS (n = 44). RBO rate was lower in the LAMS-DPS group (14 [30%] of 47 patients vs 4 [9%] of 44 patients; relative risk, 0.31; 95% confidence interval [CI], 0.09-0.78; P = .024). Hospitalization was shorter in the LAMS-DPS group (median difference, 4.5; 95% CI, 0-9; P = .016). The procedure time was longer (21 minutes vs 32 minutes; P = .018) in the LAMS-DPS group. No differences were found among technical, clinical success, and global adverse events (19 vs 27%; relative risk, 1.42; 95% CI, 0.67-3.18; P = .362).

[CONCLUSIONS] In patients with MDBO, endoscopic ultrasound-guided biliary drainage using LAMS with coaxial DPS was superior to LAMS alone. It offered clinical benefits including lower recurrent biliary obstruction rate and shorter hospitalization.

[CLINICALTRIALS] gov, Number: NCT04595058.