Clinical trial NCT05224037: Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch
Official title: Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch in Patients With Chronic Liver Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease
Liver Fibrosis
Liver Steatoses
Keywords: ilivtouch
fibroscan
liver stiffness measurement
controlled attenuation parameter
non-alcoholic fatty liver disease
liver steatosis
Lead sponsor: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Liver stiffness
timeFrame: Study day 1
measure: Controlled attenuation parameter
timeFrame: Study day 1
Secondary outcomes:
measure: Interquartile range of liver stiffness
timeFrame: Study day 1
measure: Interquartile range of the controlled attenuation parameter
timeFrame: Study day 1
measure: Success rate
timeFrame: Study day 1
measure: Stage of liver fibrosis
timeFrame: Study day 1
measure: Stage of steatosis of the liver
timeFrame: Study day 1
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Study officials:
affiliation: Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
name: Vasily Isakov, Professor
role: STUDY_CHAIR
References: