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RecruitingNot ApplicableNCT07536191

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

Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Endoscopic Transpapillary Gallbladder Drainage in Poor Surgical Candidates With Acute Calculous Cholecystitis: A Multicenter Randomized Controlled Trial (GALLVIA Trial)

Sponsor

Aichi Medical University

Enrollment

90 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Calculous Cholecystitis

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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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Interventions

PROCEDUREEndoscopic 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.

PROCEDUREEndoscopic 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.

Locations(5)

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

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NCT07536191