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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05871749
Other study ID # AsanMC_2D-SWE_ATI_CHB
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 20, 2023
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source Asan Medical Center
Contact Soyeon Kim, Professor
Phone 820230105980
Email sykim.radiology@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigator aimed to prospectively study the effect of the hepatic fibrosis on quantifying hepatic steatosis using ultrasound attenuation imaging (ATI value) in patients with chronic hepatitis B.


Description:

Chronic hepatitis B virus (HBV) infection has been reported to be associated with the prevalence of non-alcoholic fatty liver disease (NAFLD). Prior studies demonstrate that concurrent fatty liver increases risk of hepatocellular carcinoma among patients with chronic hepatitis B. Therefore, quantification of hepatic steatosis and fibrosis in chronic hepatitis B patient has important clinical significance in active surveillance. Ultrasound imaging provides reliable noninvasive quantification of hepatic steatosis and fibrosis. Attenuation imaging (ATI) reflects hepatic steatosis and 2D-shear wave elastography reflects hepatic fibrosis. The potential interaction between of the hepatic fibrosis and the hepatic steatosis in chronic hepatitis B is not fully understood. The investigator investigated the effect of the hepatic fibrosis on quantifying hepatic steatosis using ultrasound attenuation imaging (ATI value) in patients with chronic hepatitis B.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria: - Chronic hepatitis B patients - Who is scheduled for pathological exam such as liver biopsy or surgery, that can quantify hepatic steatosis and hepatic fibrosis - Who submitted informed consent Exclusion Criteria: - Who underwent liver transplantation or right hemihepatectomy - Huge hepatic mass or numerous cysts in right hepatic lobe, who is not eligible for measuring ultrasound attenuation imaging and Fibroscan - High bleeding risk patients

Study Design


Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
So Yeon Kim Canon Medical Systems, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attenuation Coefficient (AC) value at liver parenchyma decibel(dB)/cm/megahertz(MHz) During procedure
Primary Pathological hepatic steatosis Non-alcoholic Steatohepatitis(NASH) Clinical Research Network scoring system as follows: S0, <5%; S1, 5%-33%; S2, 34%-66%; S3, =67% During procedure
Primary Pathological hepatic fibrosis Meta-analysis of histological data in viral hepatitis(METAVIR) scoring system as follows: F0, no fibrosis; F1, portal fibrosis without septa; F2, portal fibrosis with rare septa; F3, numerous septa without cirrhosis; and F4, cirrhosis During procedure
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