EUS-guided versus 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)

This tests two endoscopic ways to drain the gallbladder—EUS-guided drainage with a lumen-apposing metal stent versus transpapillary drainage with a plastic stent—in adults with acute calculous cholecystitis who are poor candidates for surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aichi Medical University (other)
• Locations: 5 sites (Aichi and 4 other locations)
• Trial ID: NCT07536191 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, open-label randomized trial enrolling adults with acute calculous cholecystitis judged to be poor surgical candidates. Participants are randomized 1:1 to receive either endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent or endoscopic transpapillary gallbladder stenting (EGBS) with a transpapillary plastic stent. The primary endpoint is clinical success, defined as effective gallbladder drainage with clinical improvement without need for additional drainage; secondary endpoints include technical success, adverse events, reintervention rate, procedure time, length of stay, and 30-day mortality. The trial uses central web-based randomization and is conducted at several tertiary hospitals in Japan.

Who should consider this trial

Good fit: Adults (age ≥18) with acute calculous cholecystitis by Tokyo Guidelines criteria who are considered poor candidates for cholecystectomy and require gallbladder drainage and can give informed consent are ideal candidates.

Not a fit: Patients without gallstones, with gallbladder perforation or suspected carcinoma, surgically altered anatomy, massive ascites, concomitant bile duct obstruction, or who are unsafe for endoscopy (including pregnant patients) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the EUS-guided approach could give high-risk patients a more reliable, tube-free option for gallbladder drainage with fewer repeat procedures and better short-term outcomes.

How similar studies have performed: Nonrandomized and retrospective series have reported high technical and clinical success for EUS-GBD, but prospective randomized comparisons against transpapillary drainage have been lacking until now.

Eligibility criteria

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.

Where this trial is running

Aichi and 4 other locations

• 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)

Study contacts

• Study coordinator: Tadahisa Inoue

Conditions: Acute Calculous Cholecystitis, Endoscopic Ultrasound-Guided Gallbladder Drainage, Endoscopic Gallbladder Stenting, Poor Surgical Candidates