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

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic Ultrasound-Guided Gallbladder Drainage: Endoscopic 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: Endoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Clinical Success Rate — Within 14 days after the index gallbladder drainage procedure
  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.

Trial sites (5)

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