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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Spain
Hospital Universitario General de Villalba
RECRUITING
Collado Villalba
Contact Information
Primary
Tihomir Georgiev, MD, PhD
tihomir.georgiev@quironsalud.es
(+34)910908102
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 36
Treatments
Patients treated with Ursodeoxycholic acid
Patients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months.
Patients not treated with Ursodeoxycholic acid
Patients without prescription of Ursodeoxycholic acid
Related Therapeutic Areas
Sponsors
Leads: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

This content was sourced from clinicaltrials.gov