Actively Recruiting
GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis
Led by Aichi Medical University · Updated on 2026-04-17
90
Participants Needed
5
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute calculous cholecystitis as defined by the Tokyo Guidelines 2018
- Considered a poor surgical candidate for cholecystectomy due to clinical factors such as advanced age, comorbidities, performance status, anesthetic risk, or refusal of surgery
- Requires gallbladder drainage to treat acute cholecystitis
- Age 18 years or older at the time of consent
- Provides written informed consent before enrollment
You will not qualify if you...
- No gallstones detected
- Suspected gallbladder cancer
- Gallbladder perforation
- No gallbladder distension
- Surgically altered anatomy
- Presence of common bile duct stones
- Bile duct narrowing (stricture)
- Massive ascites
- Gastric or duodenal narrowing (stenosis)
- Considered unsafe for endoscopic procedures
- Pregnant or possibly pregnant
- Deemed unsuitable for the study by the investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Aichi Medical University
Aichi, Japan
Actively Recruiting
2
Gifu Municipal Hospital
Gifu, Japan
Actively Recruiting
3
Gifu Prefectural General Medical Center
Gifu, Japan
Actively Recruiting
4
Gifu University Hospital
Gifu, Japan
Actively Recruiting
5
Matsunami General Hospital
Gifu, Japan
Actively Recruiting
Research Team
T
Tadahisa Inoue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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