RecruitingNCT06278090

Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution

Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution. Prospective Cohort Study


Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Enrollment

36 participants

Start Date

Mar 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patients with gallbladder polyps eligible for standard follow up (without indication for cholecystectomy or patient decline surgery or polyps < 5mm without risk factors such as age>60 years, primary sclerosing cholangitis, asian ethnicity, sessile polypoid lesion)

Exclusion Criteria1

  • Patients with gallbladder polyps that received ursodeoxycolic acid doses lower than 10mg/kg/day

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Interventions

DRUGUrsodeoxycholic Acid Only Product

Ursodeoxycholic acid treatment, 10-15mg/kg/day for at least 6 months


Locations(1)

Hospital Universitario General de Villalba

Collado Villalba, Madrid, Spain

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NCT06278090