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NCT Number: NCT05871749

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

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.

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Key information

Conditions

Hepatic Steatosis Blood-Borne Infections Chronic Disease Chronic Hepatitis B Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fatty Liver Fibrosis Hepadnaviridae Infections Hepatic Fibrosis Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center, Seoul, Songpa-gu , 88, Olympic-ro 43-gil, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Attenuation Coefficient (AC) value at liver parenchyma

    Time frame: During procedure

    decibel(dB)/cm/megahertz(MHz)

  2. Pathological hepatic steatosis

    Time frame: During procedure

    Non-alcoholic Steatohepatitis(NASH) Clinical Research Network scoring system as follows: S0, <5%; S1, 5%-33%; S2, 34%-66%; S3, ≥67%

  3. Pathological hepatic fibrosis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

So Yeon Kim

Other

Collaborators

  • Canon Medical Systems, Korea

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 23, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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