Clinical trial NCT04571957: Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization
Official title: Expanding Donor Pool for Live Donor Liver Transplantation: Utilization of Donors With NASH After Optimization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent LDLT from June 2011 to January 2019 at Institute of Liver \& Biliary Sciences, New Delhi

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of donor optimization protocol on body weight in donors with biopsy proven NASH
timeFrame: 6 weeks to 3 months
measure: Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH.
timeFrame: 6 weeks to 3 months
measure: Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH.
timeFrame: 6 weeks to 3 months
measure: Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH.
timeFrame: 6 weeks to 3 months
measure: Improvement in Liver Function Test in donors with NASH after major hepatectomy.
timeFrame: Day 0 to Day 7
measure: Improvement in Coagulation Profile in donors with NASH after major hepatectomy.
timeFrame: Day 0 to Day 7
measure: Improvement in Liver Function Test between both the groups
timeFrame: Day 0 to Day 7
Secondary outcomes:
measure: Proportion of NASH among live liver donors
timeFrame: Day 0
measure: Morbidity among Live Liver Donors with NASH after major hepatectomy
timeFrame: Day 0 to Day 30
measure: Post Operative complications of recipients in both the groups
timeFrame: Day 0 to day 30
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: