Enrolling by invitation
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A Study on the Efficacy and Safety of Endoscopic Ultrasound-guided Gastro-/Duodeno-cholecystostomy for the Treatment of Gallstones.
Condition(s) studied
Gall StonesGall Stones (& [Calculus - Gall Bladder])
Investigational drug(s) / intervention(s)
cholecystolithotomy
cholecystolithotomy: EUS-GBD as a bridging procedure in combination of per-oral cholecystolithotomy
Study 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.
Eligibility
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.
Primary outcome measure(s)
- The technical success rate — From enrollment to the end of treatment at 1year
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology |
Wuhan |
Hubei |
|
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