Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch (OGIG-01-22-LF)

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Fibrosis; Chronic Liver Disease; Liver Steatoses
• Intervention / Treatment: Diagnostic test: iLivTouch

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115446
    • Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Investigators: Study Chair: Vasily Isakov, Professor, Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: liver steatosis; non-alcoholic fatty liver disease; fibroscan; controlled attenuation parameter; ilivtouch; liver stiffness measurement
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis
• Other Study ID Numbers: FGMF-2022-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: depersonalised individual participants data may be shared upon reasonable request to the principal investigator after study completion
• IPD Sharing Time Frame: after study completion
• IPD Sharing Access Criteria: request to the investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No