An interventional study of cholecystolithotomy in Gall Stones and Gall Stones (& [Calculus - Gall Bladder]), sponsored by Tongji Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
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.
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."
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 60 is below the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Tongji Hospital is the lead sponsor of 386 studies on the registry; 209 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EUS-guided gallbladder drainage in combination of per-oral cholelithiasis
Device: cholecystolithotomy
EUS-GBD as a bridging procedure in combination of per-oral cholecystolithotomy
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.
Time frame: From enrollment to the end of treatment at 1year
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.
Time frame: From enrollment to the end of treatment at 1year
The clinical success rate
Clinical success is defined as complete removal of gallstones.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 5 year.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
Of 58 non-industry interventional studies with no phase under Gallstones, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 12 and three quarters within 43.
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