Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization
1 other identifier
observational
410
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFirst Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedOctober 1, 2020
September 1, 2020
7 months
September 9, 2020
September 26, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
Effect of donor optimization protocol on body weight in donors with biopsy proven NASH
6 weeks to 3 months
Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH.
6 weeks to 3 months
Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH.
6 weeks to 3 months
Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH.
6 weeks to 3 months
Improvement in Liver Function Test in donors with NASH after major hepatectomy.
Day 0 to Day 7
Improvement in Coagulation Profile in donors with NASH after major hepatectomy.
Day 0 to Day 7
Improvement in Liver Function Test between both the groups
Day 0 to Day 7
Secondary Outcomes (3)
Proportion of NASH among live liver donors
Day 0
Morbidity among Live Liver Donors with NASH after major hepatectomy
Day 0 to Day 30
Post Operative complications of recipients in both the groups
Day 0 to day 30
Study Arms (2)
Donors with NASH
Donors with NASH underwent donor optimization protocol
Donors without NASH
Donors without NASH
Interventions
Eligibility Criteria
Patients underwent LDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi
You may qualify if:
- Live Liver Donors who had undergone major hepatectomy (removal of ≥ 3 liver segments)
You may not qualify if:
- Live Liver Donors who had undergone minor hepatectomy (removal of \< 3 liver segments)
- Live Liver Donors of recipients with acute liver failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2020
First Posted
October 1, 2020
Study Start
December 1, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
October 1, 2020
Record last verified: 2020-09