Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,333
- 试验地点
- 13
- 主要终点
- Correlation coefficients between factors and liver stiffness
研究概览
简要总结
Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver.
This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.
详细描述
The measurements of liver stiffness made by the Aixplorer® will be compared to (where available) :
- blood markers
- biopsy results
- other stiffness measurement exams (FibroScan, ARFI, ElastPQ...)
The influence of other (confounding) factors on the reliability of SWE measurements will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting a single condition below:
- •Chronic hepatitis B, defined by serology HBsAg positive and the presence of DNA / RNA in the serum, or
- •Chronic hepatitis C, defined by serology anti-HCV positive and the presence of DNA / RNA in the serum, or
- •non-alcoholic fatty-liver disease
- •And meeting all of the conditions below:
- •liver biopsy for histological evaluation of liver fibrosis
- •Length of liver biopsy ≥ 15 mm paraffin sections (except if cirrhosis)
- •Age of majority in their country
- •Obtaining the signature of consent for participation in the data collection, in addition to the routine consent form routinely used at the sites.
排除标准
- •Cause of chronic liver disease other than viral (alcohol, hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) and other than non-alcoholic fatty-liver disease
- •History of antiviral therapy for 6 months or less of current antiviral therapy
- •Any systemic, viral hepatitis and HIV co-infection
- •Pregnant woman
- •Failure to obtain consent
- •Length of all liver biopsy specimens below 15mm
结局指标
主要结局
Correlation coefficients between factors and liver stiffness
时间窗: Within one year of the study start date
Factors include patient's clinical and biological parameters
次要结局
- Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis(Within one year of the study start date)
- Diagnostic performance of multivariate models to assess liver fibrosis levels(Within one year of the study start date)
- Technical success rates depending on factors(Within one year of the study start date)