Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution

NCT06278090 | Active Not Recruiting

• 1 other identifier: AUDC
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gallbladder polyp; Ursodeoxycholic acid

Outcome Measures

Primary Outcomes (1)

• Reducing gallbladder polyp size by 2mm or more

  Reducing the polyp size by 2mm or more, at the usual ultrasonographic controls at 6 and 12 months.

  6 and 12 months

Secondary Outcomes (1)

• Modification of the expected follow up

  12 months

Study Arms (2)

Patients treated with Ursodeoxycholic acid

Patients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months.

Drug: Ursodeoxycholic Acid Only Product

Patients not treated with Ursodeoxycholic acid

Patients without prescription of Ursodeoxycholic acid

Interventions

Ursodeoxycholic Acid Only Product DRUG

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

Also known as: Ursobilane, Ursochol

Patients treated with Ursodeoxycholic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients referred for an outpatient consultation to the Departments of Surgery and Gastroenterology due to gallbladder polyps.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Hospital Universitario General de Villalba

Collado Villalba, Madrid, 28400, Spain

Location

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Tihomir Georgiev, MD, PhD

  Hospital Universitario General de Villalba, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)