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

NCT05871749 | Completed DMC

• 1 other identifier: AsanMC_2D-SWE_ATI_CHB
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Steatosis; Hepatic Fibrosis; Chronic Hepatitis b

Keywords

Ultrasound Attenuation Imaging

Outcome Measures

Primary Outcomes (3)

• Attenuation Coefficient (AC) value at liver parenchyma

  decibel(dB)/cm/megahertz(MHz)

  During procedure

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic hepatitis B patients, who is schedule for pathological exam such as liver biopsy or liver surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• So Yeon Kim: lead
• Canon Medical Systems, Korea: collaborator

Study Sites (2)

Asan Medical Center

Seoul, Songpa-gu , 88, Olympic-ro 43-gil, 05505, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pathological degree of hepatic steatosis and fibrosis

MeSH Terms

Conditions

Fatty Liver; Liver Cirrhosis; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Soyeon Kim, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 23, 2023
• Study Start: June 7, 2023
• Primary Completion: February 16, 2024
• Study Completion: June 1, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)