Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Chronic Liver Disease
|
Outcome Measures
Primary Outcome Measures
- Quality of staging fibrosis (METAVIR scoring system) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard) [singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)]
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).
Secondary Outcome Measures
- Quality of staging steatosis (four-graded scale, percentage) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard) [singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Chronic hepatopathy and necessity of liver biopsy
Exclusion Criteria:
- metal implants preventing MRI
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Medicine III, University Hospital Aachen (RWTH) | Aachen | Germany | 52074 |
Sponsors and Collaborators
- Tischendorf, Jens, M.D.
Investigators
- Principal Investigator: Holger H Lutz, M.D., Department of Medicine III, University Hospital RTWH University of Aachen
Study Documents (Full-Text)
None provided.More Information
Publications
- Bonekamp S, Kamel I, Solga S, Clark J. Can imaging modalities diagnose and stage hepatic fibrosis and cirrhosis accurately? J Hepatol. 2009 Jan;50(1):17-35. doi: 10.1016/j.jhep.2008.10.016. Epub 2008 Nov 8. Review.
- Castera L. Transient elastography and other noninvasive tests to assess hepatic fibrosis in patients with viral hepatitis. J Viral Hepat. 2009 May;16(5):300-14. doi: 10.1111/j.1365-2893.2009.01087.x. Epub 2009 Feb 25. Review.
- Faria SC, Ganesan K, Mwangi I, Shiehmorteza M, Viamonte B, Mazhar S, Peterson M, Kono Y, Santillan C, Casola G, Sirlin CB. MR imaging of liver fibrosis: current state of the art. Radiographics. 2009 Oct;29(6):1615-35. doi: 10.1148/rg.296095512. Review.
- LU-TI-01