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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Eligible subjects will undergo liver stiffness and controlled attenuation parameters examination with two devices on the same day
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, Russia
Liver stiffness
Single assessment (Median by at least 10 measurements) of the liver stiffness in kilo pascals will be performed during examination of the subject
Time frame: Study day 1
Controlled attenuation parameter
Single assessment (Median by at least 10 measurements) of the controlled attenuation parameter in kilo pascals will be performed during examination of the subject
Time frame: Study day 1
Interquartile range of liver stiffness
Single assessment (interquartile range by at least 10 measurements) of the liver stiffness in kilo pascals will be performed during examination of the subject
Time frame: Study day 1
Interquartile range of the controlled attenuation parameter
Single assessment of interquartile range of the controlled attenuation parameter (by at least 10 measurements) in kilo pascals will be performed during examination of the subject
Time frame: Study day 1
Success rate
Success rate (a quotient of division of number of successful measurement on the total of number of measurements performed during examination of a subject) with iLivTouch and Fibroscan
Time frame: Study day 1
Stage of liver fibrosis
stage of liver fibrosis according to the liver stiffness and manufacturers instruction on the interpretation of the results of iLivTouch and FibroScan
Time frame: Study day 1
Stage of steatosis of the liver
stage of liver fibrosis according to the measurement of the controlled attenuation parameter obtained during examination of a subject and manufacturers instruction on the interpretation of the results of iLivTouch and FibroScan
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Time frame: Study day 1