Accuracy of Vacuum-assisted Breast Biopsy Elite 10G Versus BARD 14G Core Needle Biopsy of Abnormal Breast Lesions.
试验速览
- 阶段
- 3 期
- 入组人数
- 1,470
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
In this study, patients whose breast ultrasound showed a space-occupying lesion and needed biopsy to clarify the pathology were selected as the research subjects. This study aims to determine whether Vacuum-assisted biopsy device Elite is superior to the traditional BARD ejection type air core needle in the diagnosis of breast cancer through a prospective randomized study.
详细描述
The main purpose of the study was to analyze the difference in the accuracy of two biopsy devices in the diagnosis of breast cancer puncture. The purpose of the secondary study was to analyze the difference between the underestimation rate, false negative rate, sensitivity, and negative predictive value of the two devices, the consistency of the immunohistochemistry between the puncture pathology and surgical pathology of the two groups of patients, the number and time-consuming of the puncture acquisition specimens, and the two biopsies Differences in the incidence of complications (safety).
If the biopsy device is a vacuum-assisted Elite 10G needle, insert the needle groove into the mass and rotate to cut the biopsy tissue one circle; If the biopsy device is a BARD 14G hollow core needle, insert the needle to the edge of the mass and pull the trigger in different directions to eject the needle to retrieve the material.
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
- 是
入选标准
- •Over 18 years old (including 18 years old)
- •Ultrasound examination indicates the presence of space-occupying lesions in the breast. The size, location, and BI-RADS classification are not limited.
- •Agree to undergo surgery after puncture
- •Ability and willingness to sign informed consent
排除标准
- •A biopsy has been performed in the external hospital
- •Contraindications for puncture or surgery such as severe coagulation dysfunction
- •Refuse breast surgery
- •Axillary lymph node puncture
结局指标
主要结局
Accuracy
时间窗: 3 months
The accuracy of the puncture pathology was defined as the proportion of patients in the study population who were consistent with the qualitative diagnosis of the puncture pathology and surgical pathology.When the pathological diagnosis of puncture is "carcinoma in situ of the catheter", if the pathological diagnosis of the catheter is "carcinoma in situ of the catheter with microinfiltration", the puncture is considered accurate;If the surgical pathology confirms "invasive cancer (infiltrating lesion \>1mm)", the pathology of the puncture is considered inaccurate (ie, underestimated)
次要结局
- Concordance of immunohistochemical marker status(3 months)
- Sensitivity(3 months)
- Underestimation Rate(3 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(7 days)
- Negative Prediction Value(3 months)