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临床试验/NCT00399815
NCT00399815Unknown不适用

Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年6月最近更新:
适应症

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

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

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other

研究点 (1)

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