Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution (GALPOL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gallbladder Polyp
• Intervention / Treatment: Drug: Ursodeoxycholic Acid Only Product

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Tihomir Georgiev, MD, PhD; Phone Number: 52220 (+34)910908102; Email: tihomir.georgiev@quironsalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive patients referred for an outpatient consultation to the Departments of Surgery and Gastroenterology due to gallbladder polyps.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with Ursodeoxycholic acid; Patients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months.	Drug: Ursodeoxycholic Acid Only Product; Ursodeoxycholic acid treatment, 10-15mg/kg/day for at least 6 months; Other Names: Ursobilane, Ursochol
Patients not treated with Ursodeoxycholic acid; Patients without prescription of Ursodeoxycholic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Investigators: Principal Investigator: Tihomir Georgiev, MD, PhD, Hospital Universitario General de Villalba, Madrid, Spain

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ursodeoxycholic acid; Gallbladder polyp
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: AUDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No