Clinical Research Directory

GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis

Sponsor: Aichi Medical University

Summary

This multicenter, prospective, open-label, randomized controlled trial compares endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with endoscopic transpapillary gallbladder drainage (EGBS) in poor surgical candidates with acute calculous cholecystitis. Eligible patients will be randomized in a 1:1 ratio to undergo either EUS-GBD using a lumen-apposing metal stent or EGBS using a transpapillary plastic stent. The primary endpoint is clinical success, defined as successful gallbladder drainage with subsequent improvement of acute cholecystitis without the need for additional gallbladder drainage. Secondary endpoints include technical success, adverse events, reintervention rate, procedure time, length of hospital stay, and 30-day mortality. The trial aims to determine whether EUS-GBD provides superior clinical outcomes compared with EGBS in this high-risk population.

Official title: Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Endoscopic Transpapillary Gallbladder Drainage in Poor Surgical Candidates With Acute Calculous Cholecystitis: A Multicenter Randomized Controlled Trial (GALLVIA Trial)

Key Details

Conditions

Interventions

Locations (5)