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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03128918
Recruitment Status : Unknown
Verified April 2017 by Giada Sebastiani, McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Canadian National Transplant Research Program
Information provided by (Responsible Party):
Giada Sebastiani, McGill University Health Center

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.

Condition or disease
Non-alcoholic Fatty Liver Disease

Detailed Description:

This is a prospective, longitudinal, pilot study of non-invasive diagnostic tests to explore recurrent or de novo NAFLD/NASH in liver transplant recipients. The study will be conducted at the Royal Victoria Hospital, McGill University Health Centre (MUHC) Solid Organ Transplant Unit, which carries out 60 liver transplants per year. A dedicated liver transplant database is in place since 1990 and prospectively collects demographic and clinical characteristics of all patients. In November 2013, two fully equipped Fibroscan machines have been acquired by the Division of Gastroenterology and Hepatology of the MUHC. The MUHC is the first center in Quebec to have access to the latest modules of Fibroscan (CAP and XL probe) that are essential to diagnose hepatic steatosis. In preparation for the current project, the Investigators performed an analysis of frequencies of hepatitis C, alcoholic liver disease, NASH, hepatitis B as indications for liver transplantation MUHC Center Solid Organ Transplant in 2000 and 2013. NASH was the only indication that significantly increased (8% in 2000 vs 20% in 2013; p<0.0001) and currently represents the third indication.

Enrolled participants will be followed every 3 months for one year, in conjunction with their regular care visit.

Blood samples obtained during the screening and the study visits will be processed by the research technician of the MUHC Solid Organ Transplant Unit. The plasma will be stored at -80C until used for quantitative measurement of CK-18 levels by the Human cytokeratin ELISA kit.

The fibroscan examination will be performed on a 4-hour fasting participants. The standard M probe will be used in all participants. The XL probe will be used in obese patients (BMI>30 Kg/m2) and in case of failure of Fibroscan by the M probe. CAP examination will be performed at the same time to diagnose hepatic steatosis. A valid Fibroscan result will be defined by 10 validated measures and IQR < 30% of the median. Validated cut-off values will be applied to diagnose hepatic steatosis and fibrosis by Fibroscan/CAP. Grading of steatosis will be as following: mild steatosis (<30% of the hepatocytes); moderate steatosis (30-60%); severe steatosis (>60%).

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients: a Prospective, Longitudinal Study Employing Serum Cytokeratin 18 and Transient Elastography (Fibroscan)
Study Start Date : July 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Primary Outcome Measures :
  1. Incidence of NASH in liver transplant recipients [ Time Frame: 18 months ]
    CK-18 to indicate NASH

  2. Evaluation of liver steatosis in liver transplant recipients [ Time Frame: 18 months ]
    Fibroscan with CAP to indicate steatosis

  3. Incidence of fibrosis [ Time Frame: 18 months ]
    Liver stiffness measurement by Fibroscan

Secondary Outcome Measures :
  1. Accuracy of noninvasive tests to diagnose NAFLD/NASH and hepatic fibrosis as compared to standard of care histology [ Time Frame: 18 months ]
    Evaluate the accuracy of CK-18 and Fibroscan/CAP

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
post liver transplant

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03128918

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Contact: Maria Osikowicz 514-934-1934 ext 31343

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Canada, Quebec
Mcgill University Health Center Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Maria Osikowicz    514-934-1934 ext 31343   
Sponsors and Collaborators
McGill University Health Center
Canadian National Transplant Research Program
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Principal Investigator: Giada Sebastiani McGill University Health Center

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Responsible Party: Giada Sebastiani, md, McGill University Health Center Identifier: NCT03128918     History of Changes
Other Study ID Numbers: 15-002-MUHC
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases