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Compares treatment options for Acute Calculous Cholecystitis
Official title GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis
ClinicalTrials.gov ID: NCT07536191
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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 likely can't join if
- No gallstones identified.
- Suspected gallbladder carcinoma.
- Gallbladder perforation.
- No gallbladder distension.
- Surgically altered anatomy.
- Concomitant common bile duct stones.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aichi, Japan
- Gifu, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aichi, Japan; Gifu, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.