Cirrhosis
Conditions
Keywords
elastography, ultrasonography
Brief summary
The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.
Detailed description
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.
Interventions
ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography.
Sponsors
Seoul National University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* volunteers who agree to undergo US shear elastography OR * patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy. AND * = or \> 18 years * sign informed consent
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic performance to detect advanced hepatic fibrosis | 1 month | from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| interobserver agreement of ultrasound SWE | 1 day | two observers perform ultrasound SWE on the same day in volunteers. |
| agreement with MR elastography | 1 month | interval between US and MR elastography in patients with available MR elastography |
| Technical success rate | 6 months | technical success or failure of US elastography using GE LOGIQ E9 scanner in ALL study population |
| Reliable measurement rate | 6 months | reliable measurement rate (interquartile range of serial measurement/median LS value \<30%) in patients with technically successful US elastography |
Countries
South Korea
Outcome results
None listed