Effect of Ursodeoxycholic Acid on Gallbladder Polyps
Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution. Prospective Cohort Study
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT06278090
This study is testing if a medication called ursodeoxycholic acid can help shrink gallbladder polyps in patients who aren't having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (other) |
| Locations | 1 site (Collado-Villalba, Madrid) |
| Trial ID | NCT06278090 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact of ursodeoxycholic acid treatment on the evolution of gallbladder polyps in patients who are under follow-up care. Participants who do not require cholecystectomy or have declined surgery will receive ursodeoxycholic acid at a dosage of 10-15 mg/kg/day for at least six months. The study will compare the size evolution of gallbladder polyps in patients receiving the treatment versus those who do not, over a one-year period. The goal is to determine if the treatment can reduce polyp size and potentially minimize the need for surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are patients with gallbladder polyps eligible for standard follow-up who do not require surgery.
Not a fit: Patients with gallbladder polyps who have received lower doses of ursodeoxycholic acid or have indications for cholecystectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could reduce the need for unnecessary surgeries in patients with gallbladder polyps.
How similar studies have performed: Previous studies have shown that ursodeoxycholic acid can be effective in managing gallbladder conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Patients with gallbladder polyps that received ursodeoxycolic acid doses lower than 10mg/kg/day
Where this trial is running
Collado-Villalba, Madrid
- Hospital Universitario General de Villalba — Collado-Villalba, Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Tihomir Georgiev, MD, PhD — Hospital Universitario General de Villalba, Madrid, Spain
- Study coordinator: Tihomir Georgiev, MD, PhD
- Email: tihomir.georgiev@quironsalud.es
- Phone: (+34)910908102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gallbladder Polyp, Gallbladder polyp, Ursodeoxycholic acid