Quantification of Hepatic Steatosis With Different Ultrasound Frequency

NCT05855239 — Unknown, 120 participants, Jong Keon Jang

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

Registry	NCT05855239
Status	Unknown
Study type	Observational
Enrollment	120 (Estimated)
Sponsor	Jong Keon Jang (Other); collaborators: Canon Medical Systems, Korea
Conditions	Fatty Liver, Fatty Liver, Nonalcoholic, Ultrasound
Dates	start 2023-06-08, primary completion 2024-06-30, completion 2024-12-31 (estimated), first posted 2023-05-11, last updated 2024-08-06
Locations	1 site in South Korea

-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.

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+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.

+Outcome measures

Primary outcomes

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%)

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

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)

+Locations (1)

Facility	City	Country	Status
Asan medical center	P’ungnap-tong, Seoul	South Korea

+Investigators

JongKeon Jang, Professor, Principal investigator, Asan Medical Center