Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch in Patients With Chronic Liver Diseases

Conditions
-----------------
Chronic Liver Disease, Liver Fibrosis, Liver Steatoses

Intervention / Treatment
-----------------
* Diagnostic Test: iLivTouch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willingness to participate on the basis of the signed informed consent form; availability of the medical records Exclusion Criteria: 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; ascites; 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>This is a single-arm study. All the participants will undergo examinations with 2 devices | Diagnostic Test: iLivTouch<br>* Eligible subjects will undergo liver stiffness and controlled attenuation parameters examination with two devices on the same day<br>* Other names: FibroScan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Study day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | Study day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ilivtouch, fibroscan, liver stiffness measurement, controlled attenuation parameter, non-alcoholic fatty liver disease, liver steatosis