Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04571957
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2020-09-09
Brief Title:
Expanding Donor Pool for Live Donor Liver Transplantation Utilization of Donors With NASH After Optimization
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Expanding Donor Pool for Live Donor Liver Transplantation Utilization of Donors With NASH After Optimization
Status:
COMPLETED
Status Verified Date:
2020-09
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:
Live donor liver transplantation LDLT is the treatment of choice for end-stage liver disease predominantly in the East where deceased donor liver transplantation is sparse In LDLT donor selection has to be stringent as the donor safety is thepriority Live liver donors LLD with complex biliary and vascular anatomy are increasingly being accepted for donation with the betterment of technical expertise One of the commonest reasons for LLD rejection is the hepatic parenchymal abnormality because ofsteatosis and steatohepatitis which can increase the donor risk Retrospective analysis of donors with non-alcoholic steatohepatitisNASH who were optimized and taken up for major hepatectomy from June 2011 to January 2018will be performed
Detailed Description:
Study Design Aim and Objective -
Primary objective
To study the effect of donor optimization protocol in donors with biopsy proven NASH
To study thebiochemical LFTSs INR recovery in donors with NASH after major hepatectomy
To compare their biochemical recovery parameters LFTs INR with that of non NASH donors
Secondary objectives
To study incidence of NASH among live liver donors
To study their respective recipients outcomes
To study the morbidity among LLDs with NASH after major hepatectomy
Methodology
Study populationPatients underwentLDLT from June 2011 to January 2019 at Institute of Liver Biliary Sciences New Delhi
Study designRetrospective study
Study periodfrom June 2011 to January 2019
Sample size with justificationAll consecutive LLDs with at least one year of follow up post-operatively
Intervention none
Monitoring and assessmentnone Statistical AnalysisCategorical variables were presented as number percentage and were compared using the Chi-square test Continuous variables were presented as mean standard deviation SD and were compared using Mann-Whitney U Test
Adverse Effects None Stopping Rule of Study None
Expected Outcome of the Project Adherence to a strict dietary and lifestyle modifications plan will cause histological reversal of NASH and fibrosis in LLDs Their clinical and biochemical recovery following the major hepatectomy will be similar to that of non-NASH LLDs
Primary objective
To study the effect of donor optimization protocol in donors with biopsy proven NASH
To study thebiochemical LFTSs INR recovery in donors with NASH after major hepatectomy
To compare their biochemical recovery parameters LFTs INR with that of non NASH donors
Secondary objectives
To study incidence of NASH among live liver donors
To study their respective recipients outcomes
To study the morbidity among LLDs with NASH after major hepatectomy
Methodology
Study populationPatients underwentLDLT from June 2011 to January 2019 at Institute of Liver Biliary Sciences New Delhi
Study designRetrospective study
Study periodfrom June 2011 to January 2019
Sample size with justificationAll consecutive LLDs with at least one year of follow up post-operatively
Intervention none
Monitoring and assessmentnone Statistical AnalysisCategorical variables were presented as number percentage and were compared using the Chi-square test Continuous variables were presented as mean standard deviation SD and were compared using Mann-Whitney U Test
Adverse Effects None Stopping Rule of Study None
Expected Outcome of the Project Adherence to a strict dietary and lifestyle modifications plan will cause histological reversal of NASH and fibrosis in LLDs Their clinical and biochemical recovery following the major hepatectomy will be similar to that of non-NASH LLDs
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