Gallstone breakthrough: no surgery needed?
NCT ID NCT07522385
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new, less invasive way to remove gallstones using a tube placed through the stomach or intestine into the gallbladder. The goal is to clear the stones while keeping the gallbladder intact, potentially avoiding the risks of traditional surgery. Sixty adults with large gallstones will be enrolled to see if the procedure works and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endoscopic ultrasound-guided gallbladder drainage and stone removal device
- What this could lead to
- If successful, this could offer a safer, less invasive alternative to gallbladder removal, preserving organ function and reducing surgical risks.
- What could go wrong
- This is an early study with only 60 participants, so results may not apply to everyone. The procedure may still carry risks like infection or stone recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
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