Validation of the New Vibration-guided FibroScan Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Echosens
- 入组人数
- 270
- 试验地点
- 5
- 主要终点
- Difference of patient percentage having a successful examination between the novel and the reference FibroScan examination
研究概览
简要总结
This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.
详细描述
Chronic liver disease (CLD) is a silent disease that can progress to life-threatening conditions. Hepatitis B (HBV) and C (HCV) viruses, alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD) are the main causes of chronic liver inflammation.
CLDs represent a major public health burden, with global estimates showing around a rate of 2 million deaths per year, including 1 million from complications of cirrhosis and 1 million from viral hepatitis and hepatocellular carcinoma. About 75 million people are diagnosed with alcohol use disorders and are at risk of developing alcohol-related liver disease. About 2 billion adults are obese or overweight and more than 400 million suffer from diabetes; both of which are risk factors for the development of NAFLD and HCC.
NAFLD is currently the leading cause of CLD worldwide with a reported worldwide prevalence of 25% in adults. Early identification among NAFLD patients with non-alcoholic steatohepatatis (NASH) and advanced fibrosis is particularly important as they are at high risk of developing liver complications. The main difficulty in diagnosing NASH patients is related to their symptomatology, which is not always clinically useful because it is not specific. Therefore a screening for advanced stage of NAFLD is recommended in patient at high risk such patients with type 2 diabetes or obesity.
Liver fibrosis is known to be a major prognostic predictor of hepatic and overall mortality in patients with CLD. Therefore, early diagnosis of liver fibrosis is crucial in asymptomatic individuals.
Liver biopsy (LB) is the gold standard diagnostic test for the evaluation of patients with CLD. However, it is difficult to use it as a screening tool given the large number of patients with NAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adult patients (age > = 18 years old) followed for a liver disease; a suspicion of liver disease or for consequences of liver disease, all etiologies combined
- •Patient must be able to give written informed consent
- •Patient affiliated to a social security system
排除标准
- •Vulnerable patient
- •Patients with ascites
研究组 & 干预措施
Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined
Adult patients followed in the Hepatology or Endocrinology department for a liver disease, all etiologies combined.
干预措施: Research FibroScan (FS) (Device)
结局指标
主要结局
Difference of patient percentage having a successful examination between the novel and the reference FibroScan examination
时间窗: 17 months
To compare the applicability between the novel FibroScan and the reference FibroScan examination performed on the liver
次要结局
- Difference between the initial localization durations required for the novel and the reference FibroScan examination.(17 months)
- ICC between novel and reference FibroScan examinations based on the operator's level expertise and coefficient of reproducibility of stiffness and CAP examination performed by the 2 different operators, on the same patient the same day.(17 months)
- Difference between the examination durations required for the novel and the reference examination based on CAP measurements.(17 months)
- Intraclass Correlation Coefficient (ICC) between novel and reference FibroScan examinations(17 months)
- Evaluation of the operator perception between the novel and reference examination(17 months)
- Difference of success rate between the novel and the reference FibroScan examination(17 months)
- Difference between the examination durations required for the novel and the reference examination based on liver stiffness measurements.(17 months)
- Evaluation of the patient perception between the novel and reference examination(17 months)
- ICC between the two novel FibroScan examinations and the two reference FibroScan examinations and coefficient of repeatability of stiffness and CAP examination performed by the same operator, on the same patient the same day.(17 months)