Predictors of Biliary Drainage Dysfunction Following EUS-Guided Gallbladder Drainage for Malignant Distal Biliary Obstruction: A Multicenter Retrospective Study: GALLBLADEUS-2.

OBJECTIVES

Endoscopic ultrasound-guided gallbladder drainage is increasingly used for malignant distal biliary obstruction, yet predictors of drainage dysfunction remain unknown. This study aimed to identify clinical and procedural factors associated with dysfunction, clinical success, and morbidity.

METHODS

This retrospective, international, multicenter cohort study included consecutive patients who underwent endoscopic ultrasound-guided gallbladder drainage with electrocautery-enhanced lumen-apposing metal stents for malignant distal biliary obstruction across 17 centers (March 2017-September 2024). The primary endpoint was biliary drainage dysfunction analyzed using Kaplan-Meier estimation and Cox regression. Secondary endpoints included predictors of clinical success and high-grade adverse events.

RESULTS

A total of 166 patients were included. Technical and clinical success rates were 98.8% (164/166) and 82.9% (136/164), respectively. Among 146 patients in the survival analysis, 12-month biliary patency was 70.4%. Neither the access route (transgastric 68.5% vs. transduodenal 73.5%, p = 0.50) nor stent diameter (8, 10, or 15 mm; p = 0.82) influenced patency. Ascites was the only independent predictor of dysfunction (HR 2.45 [95% CI 1.17-5.13], p = 0.018). Endoscopic ultrasound-confirmed cystic duct patency was independently associated with clinical success (86.7% vs. 69.4%, OR 2.88 [95% CI 1.19-6.96], p = 0.019). The 15-mm stent was associated with fewer high-grade adverse events (14.3% vs. 32.9%, OR 0.31 [95% CI 0.14-0.69], p = 0.004) without affecting patency.

CONCLUSIONS

In this large multicenter series, neither access route nor stent diameter influenced biliary patency. Ascites was the sole independent predictor of dysfunction. A protective signal of 15 mm stents against high-grade morbidity warrants prospective confirmation.