Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-05-31

Brief Summary

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Chronic viral hepatitis C is a frequent liver disease. It is associated with variable degree of hepatic fibrosis. To date, liver histology is still regarded as the gold standard to detect, diagnose and quantify liver fibrosis. This requires to perform a liver biopsy. Severe complications are associated to this procedure in 0.01 to 0.1% of cases. Because of this, the repetition of the biopsy to evaluate the progression of the disease or the response to treatment poses ethical questions. Also, liver biopsy only explore a minimal portion of the liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated.

To avoid risks linked to invasive technique and sampling errors associated to liver biopsy, efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis.

In this study we will perform in patients with chronic hepatitis C, serum tests, fibroscan (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver parenchyma by MRI.

This study will allow

* to determine whether non-invasive tests effectively measure liver fibrosis
* to compare each non-invase test with results of liver biopsy
* to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis C.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* alteration of liver function tests (ALT, AST)
* HCV RNA positive

Exclusion Criteria

* clotting disorder
* ongoing treatment with anti-coagulant or anti-aggregant
* advanced or decompensated cirrhosis (Child-Pugh class C)
* hepatocellular carcinoma
* other cancer
* history of surgery for brain aneurysm
* pace maker or defibrillator
* ocular metal foreign body

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No