Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization

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.

Study Overview

• Status: Completed
• Conditions: Non Alcoholic Steatohepatitis
• Intervention / Treatment: Other: No Intervention

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.

• Study Type: Observational
• Enrollment (Actual): 410

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent LDLT from June 2011 to January 2019 at Institute of Liver & Biliary Sciences, New Delhi

Description

Inclusion Criteria:

1. Live Liver Donors who had undergone major hepatectomy (removal of ≥ 3 liver segments)

Exclusion Criteria:

1. Live Liver Donors who had undergone minor hepatectomy (removal of < 3 liver segments)
2. Live Liver Donors of recipients with acute liver failure.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Donors with NASH; Donors with NASH underwent donor optimization protocol	Other: No Intervention; No Intervention
Donors without NASH	Other: No Intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 26, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 26, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ILBS-LIVEDONORS-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No