Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278090
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-02-19
Brief Title:
Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution
Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Organization:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Overview
Official Title:
Impact of Ursodeoxycholic Acid Treatment on the Gallbladder Polyp Evolution Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALPOL
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 mgkgday 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
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 mgkgday 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 mgkgday 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
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 mgkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None