Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-29 @ 11:31 AM
Study NCT ID:
NCT04571957
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 steatohepatitis(NASH) 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 population:Patients underwentLDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi
* Study design:Retrospective study
* Study period:from June 2011 to January 2019
* Sample size with justification:All consecutive LLDs with at least one year of follow up post-operatively
* Intervention: none
* Monitoring and assessment:none Statistical Analysis:Categorical 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 population:Patients underwentLDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi
* Study design:Retrospective study
* Study period:from June 2011 to January 2019
* Sample size with justification:All consecutive LLDs with at least one year of follow up post-operatively
* Intervention: none
* Monitoring and assessment:none Statistical Analysis:Categorical 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:
False
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?: