Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients
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|ClinicalTrials.gov 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
|Condition or disease|
|Non-alcoholic Fatty Liver Disease|
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%).
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
- Incidence of NASH in liver transplant recipients [ Time Frame: 18 months ]CK-18 to indicate NASH
- Evaluation of liver steatosis in liver transplant recipients [ Time Frame: 18 months ]Fibroscan with CAP to indicate steatosis
- Incidence of fibrosis [ Time Frame: 18 months ]Liver stiffness measurement by Fibroscan
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03128918
|Contact: Maria Osikowicz||514-934-1934 ext email@example.com|
|Mcgill University Health Center||Recruiting|
|Montreal, Quebec, Canada, H4A 3J1|
|Contact: Maria Osikowicz 514-934-1934 ext 31343 firstname.lastname@example.org|
|Principal Investigator:||Giada Sebastiani||McGill University Health Center|