EUS-guided choledochoduodenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) has been proposed as an alternative procedure in patients with distal malignant biliary obstruction (DMBO) and failed ERCP. METHODS: This multicenter, retrospective analysis included all cases of EUS-CDS with LAMS performed in patients with DMBO and failed ERCP in 23 Italian centers from January 2016 to July 2020. Primary endpoints were technical and clinical success. Secondary endpoints were the assessment of the adverse event (AE) rate and variables associated with technical success. RESULTS: Two hundred fifty-six patients (44.9% women) with a mean age of 73.9 ± 12.6 years were included in the study. The most common etiology of DMBO was pancreatic adenocarcinoma (75%), followed by ampullary cancer (8.6%) and cholangiocarcinoma (6.6%). The common bile duct median diameter was 17.3 ± 3.9 mm. Technical and clinical success were achieved in 239 of 256 (93.3%), and 230 of 239 (96.2%) patients, respectively. The mean follow-up was 151 ± 162 days. Twenty-seven AEs occurred in 25 of 239 patients (10.5%) (3 mild, 21 moderate, and 3 severe). No fatal AEs occurred. Reinterventions to manage AEs with endoscopic or radiologic procedures occurred in 22 patients (9.2%). CONCLUSIONS: The results of our study show that EUS-CDS with LAMSs in patients with DMBO and failed ERCP represent a viable alternative in terms of effectiveness and safety with acceptable AE rates. (Clinical trial registration number: NCT03903523.).