Clinical trial NCT05871749: Effects of Hepatic Fibrosis on Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Chronic Hepatitis B
Official title: Effects of Hepatic Fibrosis on Quantifying Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Patients With Chronic Hepatitis B: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Steatosis
Hepatic Fibrosis
Chronic Hepatitis b
Keywords: Ultrasound Attenuation Imaging
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Canon Medical Systems, Korea
First posted: 2023-05-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic hepatitis B patients, who is schedule for pathological exam such as liver biopsy or liver surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attenuation Coefficient (AC) value at liver parenchyma
timeFrame: During procedure
measure: Pathological hepatic steatosis
timeFrame: During procedure
measure: Pathological hepatic fibrosis
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu , 88, Olympic-ro 43-gil
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Soyeon Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: