Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Hepatitis C, Chronic |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Chronic hepatitis C
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
Contacts and Locations| Contact: Yves J Horsmans, M.D., Ph.D. | 32 2 764 28 37 | horsmans@gaen.ucl.ac.be |
| Contact: Bernard VanBeers, M.D., | 32 2 764 29 45 | vanbeers@rdgn.ucl.ac.be |
| Belgium | |
| Cliniques Universitaires StLuc, Université catholique de Louvain (UCL) | Recruiting |
| Brussels, Belgium, 1200 | |
| Study Director: | Yves J Horsmans, M.D., Ph.D. | Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium |
More Information
No publications provided
| Responsible Party: | Prof Yves Horsmans, Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT00399815 History of Changes |
| Other Study ID Numbers: | ELASTO2 |
| Study First Received: | November 14, 2006 |
| Last Updated: | September 17, 2009 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
|
Chronic viral hepatitis C HCV RNA Fibroscan Fibrotest hepatic elastography by MRI |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 17, 2013