Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution

Gallbladder Polyp Clinical Trial

— GALPOL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06278090
• Other study ID #: AUDC
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: July 2026

Study information

• Verified date: February 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
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: July 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gallbladder Polyp
• Polyps

Intervention

Drug:
• Ursodeoxycholic Acid Only Product
Ursodeoxycholic acid treatment, 10-15mg/kg/day for at least 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 and 12 months
Secondary	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.	12 months