Gall StonesNCT07522385
A Study on the Efficacy and Safety of Endoscopic Ultrasound-guided Gastro-/Duodeno-cholecystostomy for the Treatment of Gallstones.
A study testing cholecystolithotomy in people with Gall Stones and Gall Stones (& [Calculus - Gall Bladder]), run by Tongji Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gall Stones, Gall Stones (& [Calculus - Gall Bladder])
- What is being tested?
- cholecystolithotomy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
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.
Read the 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."
- Being tested
- cholecystolithotomy
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystolithotomyDevice
EUS-GBD as a bridging procedure in combination of per-oral cholecystolithotomy
| Study group | Role | What they receive |
|---|---|---|
| Gallbladder preserving surgery | Experimental | EUS-guided gallbladder drainage in combination of per-oral cholelithiasis Receives: Device: cholecystolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 1year
Secondary outcomes (5)
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.
Measured: From enrollment to the end of treatment at 1year
The clinical success rate
Clinical success is defined as complete removal of gallstones.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 5 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Jan 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall StonesStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522385
- Sponsor's protocol ID
- TJ-IRB202601041
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Endoscopic Ultrasound-guided Gastro-/Duodeno-cholecystostomy for the Treatment of Gallstones.
- ClinicalTrials.gov ID
- NCT07522385
- Acronym / sponsor ID
- TJ-IRB202601041
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gallbladder preserving surgery | Experimental | Device: cholecystolithotomyEUS-guided gallbladder drainage in combination of per-oral cholelithiasis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecystolithotomyEUS-GBD as a bridging procedure in combination of per-oral cholecystolithotomy | Device | Gallbladder preserving surgery |
Primary outcome
The technical success rate
Time frame: 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.
5 secondary outcomes
Gallbladder function
Time frame: From enrollment to the end of treatment at 1year
The clinical success rate
Time frame: From enrollment to the end of treatment at 1year
Adverse events
Time frame: From enrollment to the end of treatment at 1year
Procedure-related parameters
Time frame: From enrollment to the end of treatment at 1year
Recurrence of gallstone
Time frame: From enrollment to the end of treatment at 5 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecystolithotomy in people with Gall Stones and Gall Stones (& [Calculus - Gall Bladder]), run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The technical success rate (time frame: From enrollment to the end of treatment at 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.