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

NCT07536191 | Recruiting

• 1 other identifier: GALLVIA-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Acute Calculous Cholecystitis; Endoscopic Ultrasound-Guided Gallbladder Drainage; Endoscopic Gallbladder Stenting; Poor Surgical Candidates

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 14 days after the index gallbladder drainage procedure

Secondary Outcomes (6)

• Technical Success Rate

  At the index procedure

• Adverse Event Rate

  Within 14 days after the index procedure, with additional follow-up assessed up to 3 year

• Reintervention Rate

  Within 30 days after the index procedure, with additional follow-up assessed up to 3 year

• Procedure Time

  At the index procedure

• Length of Hospital Stay

  From the index procedure to hospital discharge, up to 30 days

Study Arms (2)

Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD)

EXPERIMENTAL

Participants undergo endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a commercially available lumen-apposing metal stent (LAMS). The gallbladder is punctured from the duodenum or stomach under endoscopic ultrasound guidance, and the stent is deployed to create internal gallbladder drainage.

Procedure: Endoscopic Ultrasound-Guided Gallbladder Drainage

Endoscopic Transpapillary Gallbladder Drainage (EGBS)

ACTIVE COMPARATOR

Participants undergo endoscopic transpapillary gallbladder drainage by ERCP-based cannulation of the bile duct and cystic duct, followed by placement of a plastic stent into the gallbladder.

Procedure: Endoscopic Transpapillary Gallbladder Drainage

Interventions

Endoscopic Ultrasound-Guided Gallbladder Drainage PROCEDURE

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 Ultrasound-Guided Gallbladder Drainage (EUS-GBD)

Endoscopic Transpapillary Gallbladder Drainage PROCEDURE

Endoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct.

Endoscopic Transpapillary Gallbladder Drainage (EGBS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aichi Medical University: lead

Study Sites (5)

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

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Tadahisa Inoue

  Department of Gastroenterology, Aichi Medical University

  STUDY CHAIR

Central Study Contacts

Tadahisa Inoue

CONTACT

+81561623311; tinoue-tag@umin.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 17, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)