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

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: Recruiting
• Conditions: Acute Calculous Cholecystitis
• Intervention / Treatment: Procedure: Endoscopic Ultrasound-Guided Gallbladder Drainage; Procedure: Endoscopic Transpapillary Gallbladder Drainage

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: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tadahisa Inoue; Phone Number: +81561623311; Email: tinoue-tag@umin.ac.jp

Study Locations

• Japan
  • Aichi, Japan
    • Recruiting
    • Aichi Medical University
    • Contact: Tadahisa Inoue; Phone Number: +81561623311; Email: tinoue-tag@umin.ac.jp
  • Gifu, Japan
    • Recruiting
    • Gifu University Hospital
    • Contact: Shinya Uemura; Phone Number: +81582306000; Email: ueshin550621@gmail.com
  • Gifu, Japan
    • Recruiting
    • Gifu Prefectural General Medical Center
    • Contact: Naoki Mita; Phone Number: +81582461111; Email: mitanao8@yahoo.co.jp
  • Gifu, Japan
    • Recruiting
    • Gifu Municipal Hospital
    • Contact: Keisuke Iwata; Phone Number: +81582511101; Email: keisukeiwata827@gmail.com
  • Gifu, Japan
    • Recruiting
    • Matsunami General Hospital
    • Contact: Mitsuru Okuno; Phone Number: +81583880111; Email: mkobdkl@yahoo.co.jp

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success Rate	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	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	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	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	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	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

• Sponsor: Aichi Medical University
• Investigators: Study Chair: Tadahisa Inoue, Department of Gastroenterology, Aichi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Acute Calculous Cholecystitis; Endoscopic Ultrasound-Guided Gallbladder Drainage; Endoscopic Gallbladder Stenting; Poor Surgical Candidates
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholecystitis, Acute
• Other Study ID 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