Safety of Endoscopic Ultrasound-Guided Biliary Drainage in Patients with Distal Malignant Biliary Obstruction with Large-Volume Ascites.

BACKGROUND/AIMS: The safety and efficacy of endoscopic ultrasound-guided biliary drainage (EUS-BD) in patients with large-volume ascites (LVA) remain unclear. We aimed to evaluate the safety of EUS-BD in patients with distal malignant biliary obstruction complicated by LVA. METHODS: This multicenter retrospective study included patients with distal malignant biliary obstruction who underwent EUS-BD. Pre-procedural computed tomography images were reviewed to identify patients with LVA, which was defined as ascites extending to the perihepatic region. The primary outcome was the safety of EUS-BD. RESULTS: Among 1,524 patients with distal malignant biliary obstruction, 156 (10.2%) had LVA. EUS-BD was performed in 43 patients in whom endoscopic retrograde cholangiopancreatography failed or was infeasible. The technical and clinical success rates for EUS-BD were 97.7% and 81.4%, respectively. Adverse events (AEs), severe AEs, and intra-abdominal AEs (bile leak and peritonitis) occurred in 34.9%, 9.3%, and 18.6% of the patients, respectively. In the multivariate analysis, peritoneal dissemination was identified as an independent risk factor for overall AEs (odds ratio, 4.57; 95% confidence interval, 1.01 to 20.65; p=0.04). In the subgroup analysis, the perihepatic ascites thickness on axial computed tomography images was significantly greater in patients with intra-abdominal AEs than in those without AEs (p<0.01). The receiver operating characteristic curve analysis showed that the perihepatic ascites thickness predicted intra-abdominal AEs (area under the curve, 0.82; optimal cutoff, 15.5 mm). Fourteen patients (32.6%) died during the index hospitalization without discharge, with a median post-procedural survival of 1.8 months. CONCLUSIONS: EUS-BD may be associated with a high risk of AEs in patients with LVA, warranting a careful selection of patients.