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临床试验/NCT01957020
NCT01957020已完成不适用

The Diagnostic Accuracy of Stereotactic Directional Vacuum-Assisted Breast Biopsy

National Taiwan University Hospital0 个研究点目标入组 130 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
主要终点
The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis

研究概览

简要总结

Stereotactic directional vacuum-assisted breast biopsy (ST DVAB) is a standard biopsy procedure for suspicious findings on mammograms in Western countries for more than 10 years [1-3], it has replaced the needle localization (NLOC) excisional biopsy for the lesions alike and was reported to feature a high sensitivity, very low delayed false-negative rate (less than 2%)[4,5]. Moreover, it causes less scarring, less psychologic stress to patients and less morbidity compared with needle localization excisional biopsy [6,7]. However, its sensitivity, accuracy has seldom been reported in Asian countries [8] , since most Asian women have different breast parenchyma pattern, different breast cancer prevalence. Therefore, we retrospectively reviewed outcomes of the two groups of patients receiving either ST DVAB or NLOC excisional biopsy, trying to investigate if ST DVAB can be an effective alternative to NLOC excisional biopsy in our country.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The indication for ST DVAB was lesions with suspicious nature for malignancy seen on mammograms which biopsy is necessitated for tissue proof, or probably benign or benign appearing lesions seen on mammograms but patients or clinicians requested biopsy

排除标准

  • 未提供

结局指标

主要结局

The sensitivity of stereotactic vacuum assisted breast biopsy for breast cancer diagnosis

时间窗: up to 5 years ( July 2008 to June 2013)

the aforementioned outcome measure-"sensitivity"- is the probability of the stereotactic vaccum assisted breast biopsy can correctly diagnose the breast cancer. And according to statistical definition, it is defined as- for those breast cancer cases, how many of them can be correctly diagnosed by stereotactic breast biopsy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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