A Study on the Efficacy and Safety of Endoscopic Ultrasound-guided Gastro-/Duodeno-cholecystostomy for the Treatment of Gallstones.

Gallstones, as a common benign gallbladder disease worldwide, have a prevalence of approximately 6.1%. Although laparoscopic cholecystectomy (LC) is currently the mainstream treatment, its associated complications cannot be overlooked, including intra-abdominal bleeding, bile leakage, intra-abdominal infection, bile duct injury, and damage to surrounding organs.

With a deeper understanding of the physiological functions of the gallbladder-such as bile concentration, lipid digestion, and neuroendocrine regulation-combined with advances in minimally invasive techniques, the concept of "gallbladder-preserving stone removal" has gradually emerged. This approach aims to remove gallstones while preserving the structure and function of the gallbladder. In recent years, choledochoscopic gallbladder-preserving surgery (CGPS) has gained consensus and been incorporated into relevant guidelines.

However, gallbladder-preserving stone removal still faces key controversies, particularly the balance between "preserving organ function" and the risks of "high stone recurrence" and "technical complexity." Exploring more minimally invasive and standardized procedures, optimizing patient selection, and improving postoperative management strategies are critical directions for overcoming these challenges.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gall Stones; Gall Stones (& [Calculus - Gall Bladder])
• Intervention / Treatment: Device: cholecystolithotomy

Detailed Description

At present, the Department of Gastroenterology at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has successfully performed 18 cases of gallbladder-preserving stone extraction using EUS-guided gallbladder drainage (EUS-GBD). Utilizing a double-flanged metal stent (Hot AXIOS™ electrocautery-enhanced delivery system), the procedure is precisely guided by endoscopic ultrasound. With the electrocautery-enabled delivery system of the stent, a "one-step" technique is used to place one flange (also known as a "mushroom head") into the gallbladder and the other into the stomach or duodenum, thereby creating a temporary anastomosis. Two weeks after the procedure, once the fistulous tract has formed, a gastroscope is advanced into the gallbladder through the stent channel, and gallstones are removed using accessories such as a retrieval basket. After confirming complete stone clearance, the stent is removed, and the fistula is closed with titanium clips.

As a natural orifice transluminal procedure, this approach offers several advantages, including minimal invasiveness, rapid postoperative recovery, avoidance of injury to surrounding organs such as the bile duct, and a low rate of postoperative complications. Moreover, it does not significantly affect subsequent surgical cholecystectomy if needed.

However, the current overall sample size remains limited. Multicenter clinical studies with larger cohorts are still required to further evaluate the stone clearance rate and recovery of gallbladder contractile function, as well as to refine procedural techniques and postoperative management strategies, ultimately achieving standardization to facilitate broader clinical application.

This study aims to evaluate the technical success rate and clinical efficacy of EUS-GBD combined with gallbladder stone extraction through a prospective clinical trial. In addition, long-term follow-up will be conducted to assess the incidence of short- and long-term postoperative complications, recovery of gallbladder function, and changes in patients' quality of life after minimally invasive, EUS-guided gallbladder-preserving stone removal. Ultimately, the study seeks to optimize the indications for this approach and to identify the best balance between "disease eradication" and "functional preservation."

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: 18-80 years;
2. Sex: Both male and female;
3. Patients diagnosed with gallstones by imaging (transabdominal ultrasound, endoscopic ultrasound, CT, or MRCP), either single or multiple stones, with a maximum stone diameter ≥1 cm, gallbladder length ≥3 cm, gallbladder wall thickness <5 mm, and with cystic duct stones or common bile duct stones excluded;
4. History of right upper abdominal pain or discomfort;
5. Gallbladder function assessment by abdominal ultrasound indicating a gallbladder ejection fraction ≥30%;
6. Willingness to preserve the gallbladder;
7. Provision of written informed consent, with understanding of the study objectives and potential risks (e.g., bile leakage, bleeding, recurrence).

Exclusion Criteria:

1. Patients with uncontrolled high fever or sepsis within 72 hours of acute cholecystitis onset (eligible for enrollment after inflammation is controlled);
2. Gallbladder perforation, gangrenous cholecystitis, or abscess formation;
3. Suspected or confirmed malignant gallbladder lesions;
4. Expected survival <6 months (e.g., advanced malignancy);
5. Anatomical limitations preventing the establishment of a stable puncture tract, such as severe gastric or duodenal stenosis/deformity, severe adhesions of the gallbladder wall, obstruction by major vessels (e.g., branches of the hepatic artery or portal vein), massive ascites, or a gallbladder completely filled with stones;
6. Prior gallbladder drainage or biliary surgery (which may interfere with outcome assessment);
7. Pregnancy, coagulation disorders (PLT <50×10⁹/L, INR >1.5 without correction), or cardiopulmonary dysfunction rendering the patient unable to tolerate the procedure;
8. Refusal to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gallbladder preserving surgery; EUS-guided gallbladder drainage in combination of per-oral cholelithiasis	Device: cholecystolithotomy; EUS-GBD as a bridging procedure in combination of per-oral cholecystolithotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The technical success rate	To evaluate the technical success rate of EUS-GBD combined with gallbladder stone extraction, defined as the successful placement of the LAMS and complete clearance of gallstones.	From enrollment to the end of treatment at 1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gallbladder function	Gallbladder function will be compared before and after the procedure on the first month, the third month, the sixth month, and the twelfth month by ultrasound. It is measured by the percentage of gallbladder emptying (ejection fraction) reflecting the degree of gallbladder emptying and representing the percentage of initial volume evacuated by the contraction of the gallbladder. Gallbladder volume changes were determined using the Dodds formula: longitudinal diameter × transverse diameter × anteroposterior diameter × 0.52. The percentage of gallbladder emptying was calculated based on the volume differences as: [(Fasting gallbladder volume - Residual gallbladder volume) / Fasting gallbladder volume)] x 100.	From enrollment to the end of treatment at 1year
The clinical success rate	Clinical success is defined as complete removal of gallstones.	From enrollment to the end of treatment at 1year
Adverse events	Adverse events include the serious adverse events (SAEs) likely related to implanting procedures of LAMS, such as bleeding, peritonitis, perforation, stent misdeployment, and stent migration; and furthermore, the mild adverse events, including fever, pneumonia, elevated liver enzyme levels, and abdominal discomfort, respectively.	From enrollment to the end of treatment at 1year
Procedure-related parameters	Procedure-related parameters include EUS-guided puncture sites either through stomach or duodenum, and the procedure time of the per-oral cholecystolithotomy is measured from the point of advancing endoscope into gallbladder via the fistula till withdrawal of the endoscope prior to closing the fistula.	From enrollment to the end of treatment at 1year
Recurrence of gallstone	Recurrence of gallstone was defined as the presence of stone that was not detected at the first ultrosonography but was found during post-procedural follow-up ultrosonography.	From enrollment to the end of treatment at 5 year.

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Cholecystolithiasis; Pathological Conditions, Signs and Symptoms; Gallstones
• Other Study ID Numbers: TJ-IRB202601041

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