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

Liver Fibrosis Clinical Trial

— OGIG-01-22-LF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05224037
• Other study ID #: FGMF-2022-0005
• Status: Completed
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Liver Steatoses

Intervention

Diagnostic Test:
• iLivTouch
Eligible subjects will undergo liver stiffness and controlled attenuation parameters examination with two devices on the same day

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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