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OpenTrials
Completed

NCT Number: NCT04571957

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.

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Key information

Conditions

Non Alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. Effect of donor optimization protocol on body weight in donors with biopsy proven NASH

    Time frame: 6 weeks to 3 months

  2. Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH.

    Time frame: 6 weeks to 3 months

  3. Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH.

    Time frame: 6 weeks to 3 months

  4. Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH.

    Time frame: 6 weeks to 3 months

  5. Improvement in Liver Function Test in donors with NASH after major hepatectomy.

    Time frame: Day 0 to Day 7

  6. Improvement in Coagulation Profile in donors with NASH after major hepatectomy.

    Time frame: Day 0 to Day 7

  7. Improvement in Liver Function Test between both the groups

    Time frame: Day 0 to Day 7

Secondary outcomes

  1. Proportion of NASH among live liver donors

    Time frame: Day 0

  2. Morbidity among Live Liver Donors with NASH after major hepatectomy

    Time frame: Day 0 to Day 30

  3. Post Operative complications of recipients in both the groups

    Time frame: Day 0 to day 30

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2020
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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