Condition: Acute Calculous Cholecystitis · Sponsor: Aichi Medical University
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.
This description comes directly from the study's public registry record.
Tadahisa Inoue · +81561623311 · tinoue-tag@umin.ac.jp
Always discuss trial participation with your own doctor first.
| Aichi Medical University | Aichi, Japan | Recruiting |
| Gifu Municipal Hospital | Gifu, Japan | Recruiting |
| Gifu Prefectural General Medical Center | Gifu, Japan | Recruiting |
| Gifu University Hospital | Gifu, Japan | Recruiting |
| Matsunami General Hospital | Gifu, Japan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07536191