Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients

NCT03128918 | Unknown

• 1 other identifier: 15-002-MUHC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple blood test, to diagnose NASH in patients who undergo liver transplantation. Liver transplantation is a life-saving procedure for people with cirrhosis. Fatty liver is a common reason for liver transplantation due to obesity and diabetes. Fatty liver can happen again to the new transplanted liver and it is often due to metabolic risk factors (including diabetes, rapid weight gain, and immunosuppressive therapy, which are used to avoid rejection of the new liver). Some patients with fatty liver after liver transplant have non-alcoholic steatohepatitis (NASH) injury to liver the tissue (inflammation) and damage which is caused by a build-up of fat in the liver. This is a serious problem and can lead to cirrhosis and loss of the transplanted liver. There has been no detailed study into the recurrence of NASH. One reason for this is one of the only ways to detect fatty liver and NASH is to have a liver biopsy, which can be painful and have complications. Recently, a new technology (Fibroscan) and a simple blood test (cytokeratin 18) have been developed which can tell doctors how much a liver is damaged and how much fat it contains without pain or complications. This is a year long study involving one screening visit and 3 study visits, 3 months apart.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

• Incidence of NASH in liver transplant recipients

  CK-18 to indicate NASH

  18 months

• Evaluation of liver steatosis in liver transplant recipients

  Fibroscan with CAP to indicate steatosis

  18 months

• Incidence of fibrosis

  Liver stiffness measurement by Fibroscan

  18 months

Secondary Outcomes (1)

• Accuracy of noninvasive tests to diagnose NAFLD/NASH and hepatic fibrosis as compared to standard of care histology

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

post liver transplant

You may qualify if:

• Liver transplant recipient of any etiology;
• \>18 years old;
• Able to provide informed consent.

You may not qualify if:

• Liver transplant due to alcoholic liver disease as primary etiology;
• Liver transplant due to chronic hepatitis C, genotype 3.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian National Transplant Research Program: collaborator

Study Sites (1)

Mcgill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Giada Sebastiani

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Osikowicz

CONTACT

514-934-1934; maria.osikowicz@mail.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: April 25, 2017
• Study Start: July 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

CA (1)