Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tischendorf, Jens, M.D.
ClinicalTrials.gov Identifier:
NCT01246388
First received: October 31, 2010
Last updated: October 19, 2014
Last verified: March 2012
  Purpose

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


Condition
Chronic Liver Disease
Steatohepatitis
Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Fibrosis and Steatosis in Patients With Chronic Hepatopathy: Non-invasive Imaging and Serum Markers vs. Liver Biopsy

Resource links provided by NLM:


Further study details as provided by Tischendorf, Jens, M.D.:

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) [ Time Frame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy) ] [ Designated as safety issue: No ]
    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) [ Time Frame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy) ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood Serum


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Liver Disease

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Chronic hepatopathy and necessity of liver biopsy

Exclusion Criteria:

  • metal implants preventing MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246388

Locations
Germany
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
  More Information

Publications:
Responsible Party: Tischendorf, Jens, M.D.
ClinicalTrials.gov Identifier: NCT01246388     History of Changes
Other Study ID Numbers: LU-TI-01
Study First Received: October 31, 2010
Last Updated: October 19, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Tischendorf, Jens, M.D.:
Fibrosis
Steatosis
Liver biopsy
Elastography
MRI

Additional relevant MeSH terms:
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014