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

NCT07536191 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-17

No results posted yet for this 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.

Conditions

  • Acute Calculous Cholecystitis

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Aichi Medical University

    lead OTHER

Principal Investigators

  • Tadahisa Inoue · Department of Gastroenterology, Aichi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07536191 on ClinicalTrials.gov