Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis B

Chronic Hepatitis b Clinical Trial

Official title:

Effects of Hepatic Fibrosis on Quantifying Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Patients With Chronic Hepatitis B: a Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05871749
• Other study ID #: AsanMC_2D-SWE_ATI_CHB
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Fatty Liver
• Fibrosis
• Hepatic Fibrosis
• Hepatic Steatosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

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