An observational study in Gallbladder Polyp, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational
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:
Participants will be managed according to the standard practice of the department they are attended:
Researchers will compare the groups that receive or not ursodeoxycolic acid treatment to see if the polyp size evolution differs significantly.
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:
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.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 70 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients referred for an outpatient consultation to the Departments of Surgery and Gastroenterology due to gallbladder polyps.
Exclusion Criteria:
Patients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months.
Drug: Ursodeoxycholic Acid Only Product
Patients without prescription of Ursodeoxycholic acid
Ursodeoxycholic acid treatment, 10-15mg/kg/day for at least 6 months
Also known as: Ursobilane, Ursochol
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.
Time frame: 6 and 12 months
Modification of the expected follow up
Depending on the polyp size, physicians could either discontinue the follow up (decreasing to \<5mm or disappearing) or indicate surgery (according to the current guidelines). Deviation from the usual evolution of the polyp size, comparing both groups, that leads to alteration of the possible follow up (termination of the follow up when polyp size reduces to \<5mm or indication of surgery when polyp size increases by 2mm or reaches 10mm) will be studied.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz