Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy.

Detailed Description
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For diagnosis, staging and grading of chronic liver disease, liver biopsy is the gold standard to date. Unfortunately, being an invasive diagnostic method, liver biopsy has a significant morbidity. Furthermore, due to the small sample size, sampling error (over- or underestimating severity of liver disease) is a serious problem in diagnostic of chronic liver disease. The objective of this study is to evaluate non-invasive diagnostic methods (MRI, elastography, ultrasound and serum parameters) in comparison to the gold standard to establish criteria for diagnostic in liver disease and reduce the necessary amount of liver biopsies in the future and allow regular follow up.

Official Title
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Evaluation of Fibrosis and Steatosis in Patients With Chronic Hepatopathy: Non-invasive Imaging and Serum Markers vs. Liver Biopsy

Conditions
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Chronic Liver Disease, Steatohepatitis, Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatopathy and necessity of liver biopsy Exclusion Criteria: metal implants preventing MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Liver Disease<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of staging fibrosis (METAVIR scoring system) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard) | Receiver operating characteristic analysis is performed (Area-under-the-ROC-curve) to evaluate non-invasive fibrosis assessment in comparison to the liver biopsy with SPSS-Software, p < 0,05 is regarded as statistically significant. METAVIR is a 5-point scale used in staging fibrosis (0 = no fibrosis, 4 = high grade fibrosis, cirrhosis). | singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of staging steatosis (four-graded scale, percentage) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard) | Receiver operating characteristic analysis is performed (Area-under-the-ROC-curve) to evaluate non-invasive steatosis assessment (MR-spectroscopy, ultrasound)in comparison to the liver biopsy with SPSS-Software, p < 0,05 is regarded as statistically significant. The degree of steatosis in liver biopsies and ultrasound is assessed by a morphological semiquantitative approach: 0: none, 1: slight, 2: moderate and 3: severe. | singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrosis, Steatosis, Liver biopsy, Elastography, MRI