Clinical trial NCT01246388: Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy
Official title: Evaluation of Fibrosis and Steatosis in Patients With Chronic Hepatopathy: Non-invasive Imaging and Serum Markers vs. Liver Biopsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Liver Disease
Steatohepatitis
Fibrosis
Keywords: Fibrosis
Steatosis
Liver biopsy
Elastography
MRI
Lead sponsor: Tischendorf, Jens, M.D.
Sponsor class: INDIV
First posted: 2010-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

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.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatopathy and necessity of liver biopsy

Exclusion Criteria:

* metal implants preventing MRI

Primary outcomes:
measure: Quality of staging fibrosis (METAVIR scoring system) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)
timeFrame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)
Secondary outcomes:
measure: Quality of staging steatosis (four-graded scale, percentage) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)
timeFrame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine III, University Hospital Aachen (RWTH)
Study officials:
affiliation: Department of Medicine III, University Hospital RTWH University of Aachen
name: Holger H Lutz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.