Noninvasive Assessement of Liver Fat in a Donor Liver

Evaluation of Fiber Optic Based Device for The Real-Time Assessment of Liver Macrovesicular Steatosis in a Human Donor

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/01/030223

Enrollment

100

Registered

2021-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age above 18 years 2. Deceased donor and live donor livers selected for donation

Exclusion criteria

Exclusion criteria: 1. Age below 18 years 2. Liver where frozen section/ standard biopsy cannot be taken

Design outcomes

Primary

Measure	Time frame
1. Validation of Real-time assessment of liver steatosis by Spectroscopy compared to frozen section/standard liver biopsy by assessing Outcome of liver transplantation using the liver assessed by spectroscopyTimepoint: 1. Day 0 - liver biopsy status 2. Day 0 - Outcome of transplanting the liver- absence of primary non function, output of bile Day 14 - Morbidity and mortality Day 30 - Morbidity and mortality Day 90 - Morbidity and Mortality	—

Measure

Time frame

1. Validation of Real-time assessment of liver steatosis by Spectroscopy compared to frozen section/standard liver biopsy by assessing Outcome of liver transplantation using the liver assessed by spectroscopyTimepoint: 1. Day 0 - liver biopsy status 2. Day 0 - Outcome of transplanting the liver- absence of primary non function, output of bile Day 14 - Morbidity and mortality Day 30 - Morbidity and mortality Day 90 - Morbidity and Mortality

—

Secondary

Measure	Time frame
Assessment of Using the donor liver in outcomes of the liver transplantation in RecipientTimepoint: 3 month mortality	—

Countries

India

Contacts

Public ContactAllwyn S Rajamani

Dr Rela Institute and Medical Centre

ashwinrammohan@gmail.com00919884173583

Outcome results