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The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.
Hepatic fibrosis causes liver dysfunction and HCC. Since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan.
The reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. In this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= > F2) will be measured using histologic grade as a reference.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound shear wave elastography | Device | ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic performance to detect advanced hepatic fibrosis | from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| interobserver agreement of ultrasound SWE | two observers perform ultrasound SWE on the same day in volunteers. | 1 day |
| agreement with MR elastography | interval between US and MR elastography in patients with available MR elastography |
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Inclusion Criteria:
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Exclusion Criteria:
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Patients who are scheduled to undergo liver resection or liver biopsy (n=138). Volunteers who agree to undergo US shear wave elastography (n=20) to determine inter-observer agreement.
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Min Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 month |
| Technical success rate | technical success or failure of US elastography using GE LOGIQ E9 scanner in ALL study population | 6 months |
| Reliable measurement rate | reliable measurement rate (interquartile range of serial measurement/median LS value <30%) in patients with technically successful US elastography | 6 months |