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

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."

Inclusion criteria

• 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).

Exclusion criteria

• 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.