NCT02413437Unknown不适用
The Multi-center Study of Percutaneous Focal Liver Lesions Biopsy Guided by Contrast-Enhanced Ultrasound
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 2,088 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,088
- 试验地点
- 1
- 主要终点
- diagnostic accuracy
研究概览
简要总结
The purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound in percutaneous biopsy for liver occupied lesion.
详细描述
The patients with liver neoplasms who need receive percutaneous biopsy were randomized into contrast-enhanced ultrasound(CEUS) group and conventional ultrasound(US) group.The aims include:
- Comparison the diagnostic accuracy rate, specificity and sensitivity between CEUS and US group.
- Comparison the diagnostic accuracy rate specificity and sensitivity between smaller(<3cm) and larger(≥3cm) nodule group.
- To explore operating strategy of contrast-enhanced ultrasound guided biopsy.
- To evaluate economic efficiency of contrast-enhanced ultrasound guided biopsy compared with conventional ultrasound guided biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •patients with liver occupied lesion who cannot be diagnosed by imaging examination or need pathological results
排除标准
- •severe anemia
- •PLT<60000/mm3,prothrombin activityprothrombin time activity<70%
- •women during menstruation, pregnancy, child birth and baby nursing period
- •patients with severe mental disorder
- •cardiopulmonary failure
结局指标
主要结局
diagnostic accuracy
时间窗: 12 months
diagnostic accuracy=（true positive+ ture negative)/number of parcitipants
次要结局
未报告次要终点
研究者
Kun Yan
Beijing Cancer Hospital
Peking University Cancer Hospital & Institute
研究点 (1)
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