NCT03047707已完成不适用
Diagnostic Performance of S-Shearwave Elastography for Hepatic Fibrosis Evaluation: a Multicenter Prospective Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Diagnostic performance to detect severe hepatic fibrosis (F3)
研究概览
简要总结
The purpose of this multi-center prospective study is to evaluate the diagnostic performance of S-Shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers
- •Signed informed consent
排除标准
- •Acute hepatitis or bile duct obstruction
- •Serum ALT> 5 times the upper limit of normal within 3 months
- •s/p Rt. hemihepatectomy
- •s/p liver transplantation
- •Large mass or infiltrative lesion in the right lobe of the liver
研究组 & 干预措施
S-Shearwave and TE
Experimental
干预措施: S-Shearwave and TE (Diagnostic Test)
结局指标
主要结局
Diagnostic performance to detect severe hepatic fibrosis (F3)
时间窗: 3 months
Reference standard: histologic diagnosis or Transient elastography
次要结局
- Determination of cut-off values of S-Shearwave measurements for fibrosis grades according to causes(3 months)
- Comparison of diagnostic performance: Shearwave vs. Transient elastography(3 months)
- Usefulness of auto-profile function in S-Shearwave measurements(3 months)
- Diagnostic value of B-mode ultrasound information for assessing hepatic fibrosis(3 months)
- Intra-observer and inter-observer agreement of S-Shearwave measurements(same day)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (1)
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