BACKGROUND AND AIMS:EUS-guided biliary drainage, creating a choledochoduodenostomy and using lumen-apposing metal stents (LAMS), is a promisingintervention 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 Nov. 2020, and Oct. 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 risk0.31[95%CI 0.09-0.78];p=0.024). Hospitalization was shorter in the LAMS-DPS group (median difference 4.5[95%CI 0, 9]; p=0.016). Procedure time was longer (21 vs 32-min, p=0.018) 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=0.362).
CONCLUSIONS:In patients with malignant distal biliary obstruction, EUS-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).