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.
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.
No gallstones identified.
Suspected gallbladder carcinoma.
Gallbladder perforation.
No gallbladder distension.
Parallel
Endoscopic Ultrasound-Guided Gallbladder Drainage
Procedure/SurgeryEndoscopic ultrasound-guided gallbladder drainage performed using a commercially available lumen-apposing metal stent (AXIOS™, Boston Scientific). The procedure is performed under endoscopic ultrasound guidance through the stomach or duodenum to achieve internal gallbladder drainage.
Endoscopic Transpapillary Gallbladder Drainage
Procedure/SurgeryEndoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct.
Clinical Success Rate
Clinical success is defined as successful gallbladder drainage followed by improvement of acute cholecystitis without the need for additional gallbladder drainage. Improvement includes resolution of fever, abdominal pain, and inflammatory findings such as leukocytosis. The primary analysis will be performed in the intention-to-treat population.
Technical Success Rate
Technical success is defined as successful completion of the assigned gallbladder drainage procedure with appropriate stent placement in the gallbladder.
Adverse Event Rate
Adverse events related to the gallbladder drainage procedure will be recorded, including bile leak, bleeding, stent migration, stent occlusion, pancreatitis, cholangitis, liver abscess, gastrointestinal perforation, biliary peritonitis, and aspiration pneumonia.
Reintervention Rate
Reintervention is defined as any additional procedure required after the initial gallbladder drainage for recurrent cholecystitis, insufficient drainage, stent-related complications, or other biliary events including cholangitis or common bile duct stones.
Procedure Time
Procedure time is defined as the time in minutes from endoscope insertion to endoscope removal during the initial gallbladder drainage procedure.
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