Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06278090 |
Other study ID # |
AUDC |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2024 |
Est. completion date |
July 2026 |
Study information
Verified date |
June 2024 |
Source |
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Contact |
Tihomir Georgiev, MD, PhD |
Phone |
(+34)910908102 |
Email |
tihomir.georgiev[@]quironsalud.es |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.