Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch in Patients With Chronic Liver Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Controlled attenuation parameter
研究概览
简要总结
This study is aimed to compare the results and operating characteristics of liver stiffness measurement with the use of Fibroscan (EchoSens, France) and iLivTouch (Wuxi Hisky Medical Technologies Co., China) in patients with chronic liver diseases.
详细描述
This is prospective comparative trial to assess diagnostic characteristics of non-invasive methods of liver fibrosis and steatosis assessment based on the measurement of liver stiffness. The null hypothesis is that novel device, iLivTouch FT100/FT200 and standard probe allows to obtain similar results of liver stiffness and controlled attenuation parameter compared to FibroScan 530 and probes M+ and XL+ in patients with chronic liver diseases. According to the study protocol, standard examination will be performed to eligible subjects on the same day with the use of both devices. At least 10 measurements will be performed with the use of each device to each subject after overnight fasting. The medians of liver stiffness and controlled attenuation parameter measurements, their interquartile range, success rate of measurements and related interpretations of the results (grades of liver fibrosis and steatosis) will be compared. To assess the variability of the results, demographic data (age, biological sex, ethnicity) will be collected; weight and height of the subjects will be measured on the day of examination. Medical history of the subjects will be examined to extract data, confirming the presence of chronic liver diseases and ensure eligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willingness to participate on the basis of the signed informed consent form;
- •availability of the medical records
排除标准
- •pregnancy and breastfeeding;
- •narrow intercostal spaces making standard examination of the liver stiffness possible;
- •extreme obesity, in cases when amount of the fat tissue in right lower part of chest makes impossible to perform measurements;
- •focal lesions of the liver (including, but not limited to liver cancer or metastases of cancer regardless of their origin, parasitic invasions, cysts) in projection of the measurements;
- •impossibility to perform evaluation with both devices due to any reasons;
- •any health-related conditions of a subject that put him/her at risk in case the procedures required per study protocol are performed or making him/her ineligible on the discretion of the investigator
结局指标
主要结局
Controlled attenuation parameter
时间窗: Study day 1
Single assessment (Median by at least 10 measurements) of the controlled attenuation parameter in kilo pascals will be performed during examination of the subject
Liver stiffness
时间窗: Study day 1
Single assessment (Median by at least 10 measurements) of the liver stiffness in kilo pascals will be performed during examination of the subject
次要结局
- Interquartile range of the controlled attenuation parameter(Study day 1)
- Success rate(Study day 1)
- Stage of liver fibrosis(Study day 1)
- Interquartile range of liver stiffness(Study day 1)
- Stage of steatosis of the liver(Study day 1)
研究者
Sergey Morozov
Leading researcher
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology