Comparison of Smart-Shear Wave Elastography and Transient Elastography
NCT ID: NCT02569567
Last Updated: 2015-11-17
Study Results
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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UNKNOWN
105 participants
OBSERVATIONAL
2015-11-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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US elastography
Participants who have the plan of liver transplantation or liver biopsy within 4 weeks will be screened from the outpatient clinic.
Two types of ultrasonographic elastography(US elastography) techniques including Smart-Shear Wave(SSW) imaging and transient elastography(TE) will be performed as a diagnostic method for hepatic fibrosis.
Smart-Shear Wave(SSW) imaging
1. All Smart-Shear Wave(SSW) imaging examinations will be performed by one operator.
2. The right lobe of the liver is examined through the intercostal view with the patient lying in a supine or semi-decubitus position with the right arm in maximal abduction.
3. Once the optimal sizes of the regions of interest is chosen, they are fixed for subsequent measurement in each subject. Special attention is paid to avoid any focal lesion, vessels, biliary tracts, or artifacts from nearby lung gas or cardiac movement.
Transient elastography(TE)
1. Using the M probe in patients with BMI \<30 kg/m2.
2. Liver measurement is taken at either the seventh or eighth intercostal space of each subject over the right lobe of the liver. The measuring depth ranges from 2.5 to 6.5 cm below the skin surface.
3. Examinations are performed by a sonographer blinded to S-shear wave elastography, and biological results.
Interventions
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Smart-Shear Wave(SSW) imaging
1. All Smart-Shear Wave(SSW) imaging examinations will be performed by one operator.
2. The right lobe of the liver is examined through the intercostal view with the patient lying in a supine or semi-decubitus position with the right arm in maximal abduction.
3. Once the optimal sizes of the regions of interest is chosen, they are fixed for subsequent measurement in each subject. Special attention is paid to avoid any focal lesion, vessels, biliary tracts, or artifacts from nearby lung gas or cardiac movement.
Transient elastography(TE)
1. Using the M probe in patients with BMI \<30 kg/m2.
2. Liver measurement is taken at either the seventh or eighth intercostal space of each subject over the right lobe of the liver. The measuring depth ranges from 2.5 to 6.5 cm below the skin surface.
3. Examinations are performed by a sonographer blinded to S-shear wave elastography, and biological results.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Potential liver donors
3. Smart-Shear wave \& transient elastography were performed within one month from liver surgery
4. Aged between 20 to 80 years
5. Compliance with scheduled visits, evaluation plans and other study procedures
Exclusion Criteria
2. Previous history of transarterial chemoembolization
3. Huge or infiltrative tumor in the right lobe of the liver
4. Bile duct dilatation in the right lobe of the liver
5. Older than 80 years
6. The opinion of the investigator would make the patient unsuitable for enrollment
20 Years
80 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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So Yeon Kim
Assistant Professor
Principal Investigators
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So Yeon Kim, Dr
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015-0782
Identifier Type: OTHER
Identifier Source: secondary_id
SMART15
Identifier Type: -
Identifier Source: org_study_id