Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution

NCT06278090 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Gallbladder Polyp

Interventions

DRUG

Ursodeoxycholic Acid Only Product

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

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Tihomir Georgiev, MD, PhD · Hospital Universitario General de Villalba, Madrid, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2027-04-30
Completion
2027-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06278090 on ClinicalTrials.gov