Acute Calculous CholecystitisGALLVIANCT07536191
GALLVIA Trial: EUS-Guided vs Transpapillary Gallbladder Drainage for Acute Calculous Cholecystitis
A study testing Endoscopic Ultrasound-Guided Gallbladder Drainage and Endoscopic Transpapillary Gallbladder Drainage in people with Acute Calculous Cholecystitis, run by Aichi Medical University at 5 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Calculous Cholecystitis
- What is being tested?
- Endoscopic Ultrasound-Guided Gallbladder Drainage and Endoscopic Transpapillary Gallbladder Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesJapan
- Study dates
- 15 Apr 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No gallstones identified.
- Suspected gallbladder carcinoma.
- Gallbladder perforation.
- No gallbladder distension.
- Surgically altered anatomy.
- Concomitant common bile duct stones.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
Aichi Medical University
Aichi
Tadahisa Inoue, +81561623311, tinoue-tag@umin.ac.jp
- Recruiting
Gifu Municipal Hospital
Gifu
Keisuke Iwata, +81582511101, keisukeiwata827@gmail.com
- Recruiting
Gifu Prefectural General Medical Center
Gifu
Naoki Mita, +81582461111, mitanao8@yahoo.co.jp
- Recruiting
Gifu University Hospital
Gifu
Shinya Uemura, +81582306000, ueshin550621@gmail.com
- Recruiting
Matsunami General Hospital
Gifu
Mitsuru Okuno, +81583880111, mkobdkl@yahoo.co.jp
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Calculous Cholecystitis
- Being tested
- Endoscopic Ultrasound-Guided Gallbladder Drainage, Endoscopic Transpapillary Gallbladder Drainage
- Keywords
- Acute Calculous Cholecystitis, Endoscopic Ultrasound-Guided Gallbladder Drainage, Endoscopic Gallbladder Stenting, Poor Surgical Candidates
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound-Guided Gallbladder DrainageProcedure or surgery
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 Transpapillary Gallbladder DrainageProcedure or surgery
Endoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endoscopic Transpapillary Gallbladder Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 14 days after the index gallbladder drainage procedure
Secondary outcomes (6)
Technical Success Rate
Technical success is defined as successful completion of the assigned gallbladder drainage procedure with appropriate stent placement in the gallbladder.
Measured: At the index procedure
Adverse Event Rate
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.
Measured: Within 14 days after the index procedure, with additional follow-up assessed up to 3 year
Reintervention Rate
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.
Measured: Within 30 days after the index procedure, with additional follow-up assessed up to 3 year
Procedure Time
Procedure time is defined as the time in minutes from endoscope insertion to endoscope removal during the initial gallbladder drainage procedure.
Measured: At the index procedure
Length of Hospital Stay
Length of hospital stay is defined as the number of days from the initial study intervention to hospital discharge.
Measured: From the index procedure to hospital discharge, up to 30 days
30-Day Mortality
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.
Measured: Within 30 days after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Calculous CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aichi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadahisa Inoue, Aichi Medical University
- Investigators
- Tadahisa Inoue, Study chair, Department of Gastroenterology, Aichi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536191
- Sponsor's protocol ID
- GALLVIA-001
- Acronym
- GALLVIA
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07536191
- Acronym / sponsor ID
- GALLVIA / GALLVIA-001
- Conditions
- Acute Calculous Cholecystitis
- Keywords
- Acute Calculous Cholecystitis, Endoscopic Ultrasound-Guided Gallbladder Drainage, Endoscopic Gallbladder Stenting, Poor Surgical Candidates
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aichi Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) | Experimental | Procedure: Endoscopic Ultrasound-Guided Gallbladder DrainageParticipants 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. |
| Endoscopic Transpapillary Gallbladder Drainage (EGBS) | Active comparator | Procedure: Endoscopic Transpapillary Gallbladder DrainageParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- No gallstones identified.
- Suspected gallbladder carcinoma.
- Gallbladder perforation.
- No gallbladder distension.
- Surgically altered anatomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Ultrasound-Guided Gallbladder DrainageEndoscopic 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 or surgery | Endoscopic Ultrasound-Guided Gallbladder Drainage (EUS-GBD) |
| Endoscopic Transpapillary Gallbladder DrainageEndoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct. | Procedure or surgery | Endoscopic Transpapillary Gallbladder Drainage (EGBS) |
Primary outcome
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.
6 secondary outcomes
Technical Success Rate
Time frame: 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
Reintervention Rate
Time frame: Within 30 days after the index procedure, with additional follow-up assessed up to 3 year
Procedure Time
Time frame: At the index procedure
Length of Hospital Stay
Time frame: From the index procedure to hospital discharge, up to 30 days
30-Day Mortality
Time frame: Within 30 days after the index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tadahisa Inoue study chair
Department of Gastroenterology, Aichi Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound-Guided Gallbladder Drainage and Endoscopic Transpapillary Gallbladder Drainage in people with Acute Calculous Cholecystitis, run by Aichi Medical University at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tadahisa Inoue (+81561623311, tinoue-tag@umin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate (time frame: Within 14 days after the index gallbladder drainage procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.