Comparison of Needle Gauge 14 vs. Gauge 16 in Breast Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Diagnostic quality
研究概览
简要总结
Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast biopsies
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Minimum age of 18 years
- •Informed consent available
- •Palpable and non-palpable breast findings
- •Tumor size 5-20 mm
- •Findings of sonographic BI-RADS® classification 2-
- •Guideline-oriented indication for bioptic clarification
排除标准
- •No reliable sonographic demarcation of the finding
- •Pregnancy
研究组 & 干预措施
14 gauge needle biopsy
breast biopsy will be performed with 14 gauge needle
干预措施: needle biopsy (Diagnostic Test)
16 gauge needle biopsy
breast biopsy will be performed with 16 gauge needle
干预措施: needle biopsy (Diagnostic Test)
结局指标
主要结局
Diagnostic quality
时间窗: 1 year
* Diagnostic quality of specimen to achieve an accurate histological diagnosis * Diagnostic quality of specimen to achieve an accurate histological diagnosis, with 1 to 5 passes of core needle biopsy * Additive diagnostic quality to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
Diagnostic accuracy
时间窗: 1 year
* Diagnostic aggreement (representativity) with definitive histology of core needle specimen and of surgical specimen * Additive diagnostic aggreement (representativity) with definitive histology of core needle specimen and with histology of surgical specimen, with 1 to 5 passes of core needle biopsy * Additive diagnostic accuracy to achieve a high (\>=99%) diagnostic yield, with 1-5 passes of core needle biopsy
次要结局
- Duration time of the biopsy procedure(1 year)
- Pain related to the biopsy procedure(1 year)