GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis
Summary
NIH registered the GALLVIA Trial (NCT07536191), a multicenter randomized controlled trial comparing endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with endoscopic transpapillary gallbladder drainage (EGBS) in poor surgical candidates with acute calculous cholecystitis. The 1:1 randomized trial uses lumen-apposing metal stents for EUS-GBD and transpapillary plastic stents for EGBS, with primary endpoint of clinical success. Secondary endpoints include technical success, adverse events, reintervention rate, procedure time, length of stay, and 30-day mortality.
What changed
NIH registered the GALLVIA Trial on ClinicalTrials.gov, establishing the official record for this randomized controlled trial comparing two gallbladder drainage techniques. The trial will enroll patients with acute calculous cholecystitis who are poor candidates for surgery, randomizing them to receive either EUS-guided drainage using a lumen-apposing metal stent or transpapillary drainage using a plastic stent.
Healthcare institutions and clinical investigators conducting or considering participation in this trial should review the protocol parameters, inclusion/exclusion criteria, and endpoints to determine relevance to their patient populations. The trial represents a prospective comparative evaluation that may inform future clinical practice guidelines for gallbladder drainage in high-risk surgical patients.
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis
N/A NCT07536191 Kind: NA Apr 17, 2026
Abstract
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.
Conditions: Acute Calculous Cholecystitis
Interventions: Endoscopic Ultrasound-Guided Gallbladder Drainage, Endoscopic Transpapillary Gallbladder Drainage
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