Overview

This trial is active, not recruiting.

Conditions chronic liver disease, steatohepatitis, fibrosis
Sponsor Tischendorf, Jens, M.D.
Start date May 2010
End date September 2014
Trial size 50 participants
Trial identifier NCT01246388, LU-TI-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

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)
time frame: 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)
time frame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Chronic hepatopathy and necessity of liver biopsy Exclusion Criteria: - metal implants preventing MRI

Additional Information

Official title Evaluation of Fibrosis and Steatosis in Patients With Chronic Hepatopathy: Non-invasive Imaging and Serum Markers vs. Liver Biopsy
Principal investigator Holger H Lutz, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Tischendorf, Jens, M.D..