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

NCT07522385 | Enrolling By Invitation

• 1 other identifier: TJ-IRB202601041
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gall Stones; Gall Stones (& [Calculus - Gall Bladder])

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Gallbladder function

  From enrollment to the end of treatment at 1year

• The clinical success rate

  From enrollment to the end of treatment at 1year

• Adverse events

  From enrollment to the end of treatment at 1year

• Procedure-related parameters

  From enrollment to the end of treatment at 1year

• Recurrence of gallstone

  From enrollment to the end of treatment at 5 year.

Study Arms (1)

Gallbladder preserving surgery

EXPERIMENTAL

EUS-guided gallbladder drainage in combination of per-oral cholelithiasis

Device: cholecystolithotomy

Interventions

cholecystolithotomy DEVICE

EUS-GBD as a bridging procedure in combination of per-oral cholecystolithotomy

Gallbladder preserving surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-80 years;
• Sex: Both male and female;
• 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;
• History of right upper abdominal pain or discomfort;
• Gallbladder function assessment by abdominal ultrasound indicating a gallbladder ejection fraction ≥30%;
• Willingness to preserve the gallbladder;
• Provision of written informed consent, with understanding of the study objectives and potential risks (e.g., bile leakage, bleeding, recurrence).

You may not qualify if:

• Patients with uncontrolled high fever or sepsis within 72 hours of acute cholecystitis onset (eligible for enrollment after inflammation is controlled);
• Gallbladder perforation, gangrenous cholecystitis, or abscess formation;
• Suspected or confirmed malignant gallbladder lesions;
• Expected survival \<6 months (e.g., advanced malignancy);
• 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;
• Prior gallbladder drainage or biliary surgery (which may interfere with outcome assessment);
• Pregnancy, coagulation disorders (PLT \<50×10⁹/L, INR \>1.5 without correction), or cardiopulmonary dysfunction rendering the patient unable to tolerate the procedure;
• Refusal to sign informed consent.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 13, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)