Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06091787
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-19
First Post:
2023-10-05
Brief Title:
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy An Open Label Randomised Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The goal of this open label randomized trial is to understand the role of oral ursodeoxycholic acidUDCA supplementation in the liver regeneration in terms of liver function and anatomical growth following right lobe donor hepatectomy The main question it aims to answer are
Does Ursodeoxycholic acid supplementation on patients undergoing donor hepatectomy improve anatomical liver regeneration after partial hepatectomy as compared to control group
Does ursodeoxycholic acid improve liver regeneration in terms of liver function tests and biomarkers of liver regenerationHGF IL6 TNF Alpha AFP TGF Beta as compared to control group
Does Ursodeoxycholic acid supplementation on patients undergoing donor hepatectomy improve anatomical liver regeneration after partial hepatectomy as compared to control group
Does ursodeoxycholic acid improve liver regeneration in terms of liver function tests and biomarkers of liver regenerationHGF IL6 TNF Alpha AFP TGF Beta as compared to control group
Detailed Description:
This open label randomized control study aims to analyze the effect of ursodeoxycholic acid supplementation on liver regeneration following a right donor hepatectomy All eligible live donors who undergo right donor hepatectomy during the study period will be included in the study and randomized into two groups One group will receive Tab UDCA 450mg twice daily for 10 days and the other group will not receive Tab UDCA Live donors who are not willing to participate in the study have hypersensitivity to UDCA or have used Tab UDCA in the past 2 weeks will be excluded from the study All live donors will be screened in the pre-operative period in the outpatient department
Pre- operative intra-operative and post-operative data will be collected from medical records electronic hospital information system HIS and radiological images collected from the hospital Picture archiving and communication systemPACS The enrolled subjects will be followed up till for a period of 14 days after the donor hepatectomy till Non contrast CT Abdomen is done and regenerated liver volumes are analyzed The anatomicvolumetric functionalliver function tests and regenerative biomarkers HGF TNF-Alpha IL6 AFP TGF-Beta will be compared between the two groups
Pre- operative intra-operative and post-operative data will be collected from medical records electronic hospital information system HIS and radiological images collected from the hospital Picture archiving and communication systemPACS The enrolled subjects will be followed up till for a period of 14 days after the donor hepatectomy till Non contrast CT Abdomen is done and regenerated liver volumes are analyzed The anatomicvolumetric functionalliver function tests and regenerative biomarkers HGF TNF-Alpha IL6 AFP TGF-Beta will be compared between the two groups
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?:
False
Is an FDA AA801 Violation?:
None