Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution
- Conditions
- Gallbladder Polyp
- Interventions
- Drug: Ursodeoxycholic Acid Only Product
- Registration Number
- NCT06278090
- Lead Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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)
- Patients with gallbladder polyps that received ursodeoxycolic acid doses lower than 10mg/kg/day
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated with Ursodeoxycholic acid Ursodeoxycholic Acid Only Product Patients that recieved prescription for Ursodeoxycholic acid, 10-15 mg/kg for at least 6 months.
- Primary Outcome Measures
Name Time Method Reducing gallbladder polyp size by 2mm or more 6 and 12 months Reducing the polyp size by 2mm or more, at the usual ultrasonographic controls at 6 and 12 months.
- Secondary Outcome Measures
Name Time Method Modification of the expected follow up 12 months 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.
Trial Locations
- Locations (1)
Hospital Universitario General de Villalba
🇪🇸Collado-Villalba, Madrid, Spain