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

RecruitingNAAges 18 Years - anyAllAichi Medical University
NCT07536191 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion 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. Exclusion Criteria: * 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.
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What it tests

  • Endoscopic Ultrasound-Guided Gallbladder Drainage
  • Endoscopic Transpapillary Gallbladder Drainage
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Where

5 sites
Aichi Medical University
Aichi, Japan
Gifu Municipal Hospital
Gifu, Japan
Gifu Prefectural General Medical Center
Gifu, Japan
Gifu University Hospital
Gifu, Japan
Matsunami General Hospital
Gifu, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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