GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis
Recruiting now · Not applicable
Conditions studied: Acute Calculous Cholecystitis
In brief
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.
Key facts
- Study ID
- NCT07536191
- Run by
- Aichi Medical University
- People needed
- 90
- Starts
- 2026-04-15
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with acute calculous cholecystitis according to the Tokyo Guidelines 2018 diagnostic criteria.
- Poor surgical candidate for cholecystectomy, determined comprehensively based on clinical condition, including advanced age, comorbidities, performance status, anesthetic risk, or patient refusal of surgery.
- Requires gallbladder drainage for treatment of acute cholecystitis.
- Age 18 years or older at the time of consent.
- Provides written informed consent before study enrollment.
You may not qualify if…
- No gallstones identified.
- Suspected gallbladder carcinoma.
- Gallbladder perforation.
- No gallbladder distension.
- Surgically altered anatomy.
- Concomitant common bile duct stones.
- Bile duct stricture.
- Massive ascites.
- Gastric or duodenal stenosis.
- Considered unsafe for endoscopic intervention.
- Pregnant or possibly pregnant.
- Judged unsuitable for the study by the investigator.
Where it is running
- Aichi Medical University — Aichi, Japan (enrolling)
- Gifu Municipal Hospital — Gifu, Japan (enrolling)
- Gifu Prefectural General Medical Center — Gifu, Japan (enrolling)
- Gifu University Hospital — Gifu, Japan (enrolling)
- Matsunami General Hospital — Gifu, Japan (enrolling)
Full record on ClinicalTrials.gov
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