Cholecystectomy vs EUS-guided GBD With Stone Removal (NCT06038201) | Clinical Trial Compass
UnknownNot Applicable
Cholecystectomy vs EUS-guided GBD With Stone Removal
Ecuador56 participantsStarted 2023-10-25
Plain-language summary
In this new era of less invasive procedures, the indications for endoscopic ultrasound (EUS)-guided gallbladder drainage (GBD) are rapidly expanding. Nowadays, the standard treatment for uncomplicated cholelithiasis (symptomatic patients not requiring hospital admission or non-surgically managed during one or more hospital admissions) is elective laparoscopic cholecystectomy.
To avoid the complications, difficulties and disadvantages of cholecystectomy, the investigators proposed a single-center study to determine the safety and effectiveness of EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone removal in patients with cholelithiasis, in comparison with the gold standard treatment, the elective laparoscopic cholecystectomy.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults \>18 years old and \<89 years old
* Adult symptomatic patients with gallstones documented by US
* Subject is a suitable candidate for an elective laparoscopic cholecystectomy or an EUS-guided GBD
* Patients or authorized representative give informed consent for endoscopic or surgical approach
Exclusion Criteria:
* Patients with hepato-pancreato-biliary diseases other than gallstones (tumors, obstructions, inflammation)
* Patients with acute cholecystitis, cholangitis or choledocholithiasis.
* Patients with gallbladder polyps, family history of gallbladder cancer, or any other high-risk factor for gallbladder cancer
* Patient unable to give informed consent or refuse to participate.
* Prior biliary intervention
* Pregnancy or nursing
* Any other medical condition that contraindicates surgical or endoscopic procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Technical success after surgical and endoscopic intervention
Timeframe: Up to 6 hours
2
Resolution of biliary symptoms
Timeframe: up to 12 months
3
Adverse events after the surgical procedures
Timeframe: up to 14 days
4
Adverse events after the endoscopic procedures
Timeframe: Up to 14 days
Trial details
NCT IDNCT06038201
SponsorInstituto Ecuatoriano de Enfermedades Digestivas