Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution

Last updated: June 10, 2024
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Polyps

Treatment

Ursodeoxycholic Acid Only Product

Clinical Study ID

NCT06278090
AUDC
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Ursodeoxycholic Acid Only Product
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
July 31, 2026

Study Description

Gallbladder polyps are common findings on abdominal ultrasound studies. Most of them are cholesterol polyps. However, often they require a prolonged follow up due to impossibility to efficiently rule out the presence of a real adenomatous polyps with potential of malignization.

Ursodeoxycholic Acid is a well-studied and long known drug that has been used for conservative treatment of bile stones with high cholesterol concentration (most of them), but also for bile sludge and gallbladder polyps, that are considered precursors of the gallbladder stones. It has been found in several studies that prevent from recurrent idiopathic acute pancreatitis and from gallbladder stone formation after gastric (including bariatric) surgery.

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 differ significantly during the studied period of 1 year. The small size changes could have a great impact on the management of the gallbladder polyps as for a 2mm increase could be a reason to indicate a surgical intervention and a 2mm decrease could cause the discontinuation of the follow up.

Connect with a study center

  • Hospital Universitario General de Villalba

    Collado-Villalba, Madrid 28400
    Spain

    Active - Recruiting

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