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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01246388
Other study ID # LU-TI-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 31, 2010
Last updated October 19, 2014
Start date May 2010
Est. completion date December 2014

Study information

Verified date March 2012
Source Tischendorf, Jens, M.D.
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chronic hepatopathy and necessity of liver biopsy

Exclusion Criteria:

- metal implants preventing MRI

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Germany Department of Medicine III, University Hospital Aachen (RWTH) Aachen

Sponsors (1)

Lead Sponsor Collaborator
Tischendorf, Jens, M.D.

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) No
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