Quantification of Hepatic Steatosis With Different Ultrasound Frequency

NCT ID: NCT05855239

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-08

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Fatty Liver Fatty Liver, Nonalcoholic Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canon Medical Systems, Korea

UNKNOWN

Sponsor Role collaborator

Jong Keon Jang

OTHER

Sponsor Role lead

Responsible Party

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Jong Keon Jang

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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JongKeon Jang, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan medical center

P’ungnap-tong, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ATI_Freq_01

Identifier Type: -

Identifier Source: org_study_id

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