Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- diagnostic performance to detect advanced hepatic fibrosis
研究概览
简要总结
The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •= or > 18 years
- •sign informed consent
排除标准
- 未提供
结局指标
主要结局
diagnostic performance to detect advanced hepatic fibrosis
时间窗: 1 month
from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis)
次要结局
- interobserver agreement of ultrasound SWE(1 day)
- Reliable measurement rate(6 months)
- agreement with MR elastography(1 month)
- Technical success rate(6 months)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital