Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy

Evaluation of Fibrosis and Steatosis in Patients With Chronic Hepatopathy: Non-invasive Imaging and Serum Markers vs. Liver Biopsy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01246388

Enrollment

Registered

2010-11-23

Start date

2010-05-31

Completion date

2014-12-31

Last updated

2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease, Fibrosis, Steatohepatitis

Keywords

Fibrosis, Steatosis, Liver biopsy, Elastography, MRI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Chronic hepatopathy and necessity of liver biopsy

Exclusion criteria

* metal implants preventing MRI

Design outcomes

Primary

Measure	Time frame	Description
Quality of staging fibrosis (METAVIR scoring system) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)	singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)	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

Measure	Time frame	Description
Quality of staging steatosis (four-graded scale, percentage) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)	singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)	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.

Countries

Germany

Outcome results