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

April 11, 2026 updated by: Tadahisa Inoue, Aichi Medical University

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Acute calculous cholecystitis is a common condition for which early laparoscopic cholecystectomy is the standard treatment. However, some patients are poor surgical candidates because of advanced age, severe comorbidities, poor performance status, or refusal of surgery. In such cases, gallbladder drainage is required.

Endoscopic gallbladder drainage has become an alternative to percutaneous drainage because it avoids external drainage tubes and may improve patient comfort and quality of life. Endoscopic transpapillary gallbladder drainage (EGBS) is an established endoscopic approach, but it is technically challenging because selective cannulation of the cystic duct is often difficult. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) has recently emerged as a promising alternative with high technical and clinical success rates. However, prospective randomized evidence directly comparing EUS-GBD with EGBS is lacking.

This study is a multicenter, prospective, parallel-group, open-label randomized controlled trial designed to compare EUS-GBD and EGBS in poor surgical candidates with acute calculous cholecystitis. After written informed consent and confirmation of eligibility, participants will be randomized in a 1:1 ratio to either the EUS-GBD group or the EGBS group using a web-based central registration system. In the EUS-GBD group, gallbladder drainage will be performed under endoscopic ultrasound guidance using a commercially available LAMS. In the EGBS group, gallbladder drainage will be performed by a transpapillary approach with placement of a plastic stent. Procedures will be performed as early as possible after enrollment, preferably within 24 hours.

The primary endpoint is clinical success, defined as successful gallbladder drainage followed by improvement of acute cholecystitis without the need for additional gallbladder drainage. Secondary endpoints include technical success, procedure-related adverse events, reintervention rate, procedure time, length of hospital stay, and 30-day mortality. Long-term follow-up data, including recurrent cholecystitis, late adverse events, reinterventions, and survival, will also be collected.

The study aims to establish high-level evidence regarding the optimal endoscopic gallbladder drainage strategy for poor surgical candidates with acute calculous cholecystitis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Aichi, Japan
        • Recruiting
        • Aichi Medical University
        • Contact:
      • Gifu, Japan
        • Recruiting
        • Gifu University Hospital
        • Contact:
      • Gifu, Japan
        • Recruiting
        • Gifu Prefectural General Medical Center
        • Contact:
      • Gifu, Japan
      • Gifu, Japan
        • Recruiting
        • Matsunami General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD)
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 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.
Active Comparator: Endoscopic Transpapillary Gallbladder Drainage (EGBS)
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
Endoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Success Rate
Time Frame: 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.
Within 14 days after the index gallbladder drainage procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical Success Rate
Time Frame: At the index procedure
Technical success is defined as successful completion of the assigned gallbladder drainage procedure with appropriate stent placement in the gallbladder.
At the index procedure
Adverse Event Rate
Time Frame: Within 14 days after the index procedure, with additional follow-up assessed up to 3 year
Adverse events related to the gallbladder drainage procedure will be recorded, including bile leak, bleeding, stent migration, stent occlusion, pancreatitis, cholangitis, liver abscess, gastrointestinal perforation, biliary peritonitis, and aspiration pneumonia.
Within 14 days after the index procedure, with additional follow-up assessed up to 3 year
Reintervention Rate
Time Frame: Within 30 days after the index procedure, with additional follow-up assessed up to 3 year
Reintervention is defined as any additional procedure required after the initial gallbladder drainage for recurrent cholecystitis, insufficient drainage, stent-related complications, or other biliary events including cholangitis or common bile duct stones.
Within 30 days after the index procedure, with additional follow-up assessed up to 3 year
Procedure Time
Time Frame: At the index procedure
Procedure time is defined as the time in minutes from endoscope insertion to endoscope removal during the initial gallbladder drainage procedure.
At the index procedure
Length of Hospital Stay
Time Frame: From the index procedure to hospital discharge, up to 30 days
Length of hospital stay is defined as the number of days from the initial study intervention to hospital discharge.
From the index procedure to hospital discharge, up to 30 days
30-Day Mortality
Time Frame: Within 30 days after the index procedure
All-cause mortality within 30 days after gallbladder drainage will be assessed. Cause of death, including whether it was related to cholecystitis or the procedure, will be recorded when available.
Within 30 days after the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aichi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tadahisa Inoue, Department of Gastroenterology, Aichi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GALLVIA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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