Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Liver Disease |
Not provided
| 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) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
in- and outclinic patients of the RTWH University Hospital (Department of Medicine III) with chronic hepatopathy and the necessity of undergoing liver biopsy for diagnostic work up
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Holger H Lutz, M.D. | Department of Medicine III, University Hospital RTWH University of Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine III, University Hospital Aachen (RWTH) | Aachen | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19254351 | Background | 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. | |
| 19022517 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood Serum
| singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy) |
| 19959511 | Background | 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. |