Quantification of Hepatic Steatosis With Different Ultrasound Frequency

Quantification of Hepatic Steatosis in Patients With Fatty Liver Disease Using Attenuation Imaging With Different Ultrasound Frequency

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05855239

Enrollment

120

Registered

2023-05-11

Start date

2023-06-08

Completion date

2024-12-31

Last updated

2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Fatty Liver, Nonalcoholic, Ultrasound

Keywords

Hepatic steatosis, Quantification, Ultrasound, Attenuation coefficient

Brief summary

The objective of this study is: (1) to compare the feasibility (technical successes rate and reliability) in measuring attenuation coefficient between two different frequencies (3MHz, 4MHz) of ultrasound beam; (2) to evaluate and compare the diagnostic performance of attenuation coefficient for steatosis using two different frequencies (3MHz, 4MHz) of ultrasound beam by comparison with the pathologic results acquired by liver biopsy or surgery.

Detailed description

Investigators measure the distance between the skin and liver capsule on B-mod images. Investigators place a region of interest (ROI) avoiding reverberation artifacts and acquire attenuation coefficient for five times. For participants who require a liver biopsy, investigators try to target the same area in the liver, where ROI was placed. Investigators evaluate hepatic steatosis, lobular inflammation, and fibrosis of tissue of the liver using a scoring system suggested by Nonalcoholic Steatohepatitis Clinical Research Network.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants who are candidates for liver donation and scheduled liver biopsies for assessment of hepatic steatosis * Participants suspected of nonalcoholic fatty liver disease and scheduled for liver biopsy or surgery

Exclusion criteria

* Participants with a BMI of less than 23 * Participants underwent liver transplantation or right hepatectomy * Participants who have a large mass in the right liver * Participants who have a bleeding tendency (platelet count \< 80000, prothrombin time and international normalized ratio \> 1.5)

Design outcomes

Primary

Measure	Time frame	Description
Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging	During procedure	dB/cm/MHz
Percentage of fat within hepatocyte in pathological specimen	During procedure	S0 (\<5%), S1(5%\ 33%), S2(34%\ 66%), and S3 (\>66%)

Countries

South Korea

Outcome results