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Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution

Study acronym: GALPOL
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Feb 2026 to Apr 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 2026 to Jul 2027
    • Site details revised
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 2024 to Mar 1, 2024
    v3
  3. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study title revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to learn about the impact of ursodeoxycholic acid treatment on the gallbladder polyp evolution in patients with gallbladder polyps that undergo follow up. The main question it aims to answer is: • Whether ursodeoxycholic acid could decrease the gallbladder polyp size and therefore spare unnecessary follow up or surgical interventions Participants will be managed according to the standard practice of the department they are attended: * According to the established practice in the Department of Surgery, patients that either do not have an indication for cholecystectomy or decline the offered intervention, and are subjects for a follow up, are usually prescribed Ursodeoxycholic Acid, at 10-15 mg/kg/day for at least 6 months. * According to the standard practice of Gastroenterology Department, patients are followed up according to the published guidelines. Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly.
Trial Details
NCT Number NCT06278090
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions
(from sponsor)		 Gallbladder Polyp
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov