Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •alteration of liver function tests (ALT, AST)
- •HCV RNA positive
排除标准
- •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
