NCT07522385

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

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."

Conditions

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

Interventions

Type	Name	Description
DEVICE	cholecystolithotomy	EUS-GBD as a bridging procedure in combination of per-oral cholecystolithotomy

Timeline

• Start date: 2026-01-20
• Primary completion: 2027-01-20
• Completion: 2027-01-20
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China