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

Completed

• Conditions: Hepatic Steatosis; Chronic Hepatitis b; Hepatic Fibrosis

• Registration Number: NCT05871749
• Lead Sponsor: So Yeon Kim

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-21
• Study First Posted: 2023-05-23
• Study Start: 2023-06-07
• Primary Completion: 2024-02-16
• Study Completion: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Attenuation Coefficient (AC) value at liver parenchyma	During procedure	decibel(dB)/cm/megahertz(MHz)
Pathological hepatic steatosis	During procedure	Non-alcoholic Steatohepatitis(NASH) Clinical Research Network scoring system as follows: S0, \<5%; S1, 5%-33%; S2, 34%-66%; S3, ≥67%
Pathological hepatic fibrosis	During procedure	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of