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临床试验/NCT01784484
NCT01784484Unknown不适用

Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes

Assy Nimer1 个研究点 分布在 1 个国家开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
试验地点
1
主要终点
liver stiffness

研究概览

简要总结

BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values will emerge as the most important independent predictive variable of fibrosis and not serum ALT. A significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with NAFLD.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects
  • More than 18 years of age
  • Patients with elevated liver enzymes
  • Written informed consent

排除标准

  • Patients refusing to participate to the study and to provide written informed consent
  • 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

结局指标

主要结局

liver stiffness

时间窗: one year

次要结局

未报告次要终点

研究者

发起方
Assy Nimer
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Assy Nimer

Prof. Assy Nimer

Ziv Hospital

研究点 (1)

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