Status:
RECRUITING
Cholecystectomy vs EUS-guided GBD With Stone Removal
Lead Sponsor:
Instituto Ecuatoriano de Enfermedades Digestivas
Conditions:
Cholelithiasis
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief 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...
Detailed Description
Currently, elective laparoscopic cholecystectomy (LC), is the preferred management for cholelithiasis in patients with history of gallstones-related adverse events, increased risk for gallbladder canc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06038201
Start Date
October 25 2023
End Date
November 2 2024
Last Update
March 29 2024
Active Locations (1)
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1
Instituto Ecuatoriano de Enfermedades Digestivas
Guayaquil, Guayas, Ecuador, 090505