Comparing gallbladder drainage methods for gallstones treatment
Cholelithiasis Management: Elective Laparoscopic Cholecystectomy vs EUS-guided Gallbladder Cholecystostomy for Gallstones Clearance
NA · Instituto Ecuatoriano de Enfermedades Digestivas · NCT06038201
This study is testing a less invasive method for treating gallstones to see if it can help adults recover faster and with fewer complications compared to traditional surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Instituto Ecuatoriano de Enfermedades Digestivas (other) |
| Locations | 1 site (Guayaquil, Guayas) |
| Trial ID | NCT06038201 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of EUS-guided gallbladder drainage (GBD) with electrocautery-enhanced lumen-apposing metal stent (LAMS) compared to the standard elective laparoscopic cholecystectomy for patients with symptomatic cholelithiasis. The aim is to determine if the less invasive EUS-guided approach can reduce complications and recovery time associated with traditional surgery. Participants will be adults with documented gallstones who are suitable candidates for either treatment. The study will be conducted at a single center in Ecuador.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 89 with symptomatic gallstones who can consent to either treatment.
Not a fit: Patients with other biliary diseases, acute conditions, or high-risk factors for gallbladder cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer, less invasive alternative to surgery for patients with gallstones.
How similar studies have performed: Similar studies have shown promising results for EUS-guided approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guayaquil, Guayas
- Instituto Ecuatoriano de Enfermedades Digestivas — Guayaquil, Guayas, Ecuador (RECRUITING)
Study contacts
- Principal investigator: Carlos Robles-Medranda, MD, FASGE — Instituto Ecuatoriano de Enfermedades Digestivas
- Study coordinator: Carlos Robles-Medranda, MD, FASGE
- Email: carlosoakm@yahoo.es
- Phone: +59342109180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholelithiasis, biliary, cholecystostomy, laparoscopic, cholecystectomy, gallstones