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

Non Alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571957
• Other study ID #: ILBS-LIVEDONORS-03
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of donor optimization protocol on body weight in donors with biopsy proven NASH		6 weeks to 3 months
Primary	Effect of donor optimization protocol on liver attenuation index in donor with biopsy proven NASH.		6 weeks to 3 months
Primary	Effect of donor optimization protocol on lipid profile in donors with biopsy proven NASH.		6 weeks to 3 months
Primary	Effect of donor optimization protocol on Liver Function Test in donors with biopsy proven NASH.		6 weeks to 3 months
Primary	Improvement in Liver Function Test in donors with NASH after major hepatectomy.		Day 0 to Day 7
Primary	Improvement in Coagulation Profile in donors with NASH after major hepatectomy.		Day 0 to Day 7
Primary	Improvement in Liver Function Test between both the groups		Day 0 to Day 7
Secondary	Proportion of NASH among live liver donors		Day 0
Secondary	Morbidity among Live Liver Donors with NASH after major hepatectomy		Day 0 to Day 30
Secondary	Post Operative complications of recipients in both the groups		Day 0 to day 30