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NCT07536191: GALLVIA

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

Recruiting now NA Last updated 17 April 2026
What this trial tests

NA trial testing Endoscopic Ultrasound-Guided Gallbladder Drainage in Acute Calculous Cholecystitis in 90 participants. Currently enrolling.

Timeline
15 April 2026
Primary endpoint
31 December 2027
31 December 2030

Quick facts

Lead sponsorAichi Medical University
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment90
Start date15 April 2026
Primary completion31 December 2027
Estimated completion31 December 2030
Sites5 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Aichi Medical University

Who can join

18 and older, any sex, with Acute Calculous Cholecystitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Aichi Medical University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07536191.

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