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.