Comparison of the Accuracy and Safety of Biopsy in Suspicious Axillary Lymph Nodes With a Crypo-assisted Stick Freeze Biopsy Device or Fine Needle Aspiration
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Sensitivity of biopsy
研究概览
简要总结
Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.
详细描述
This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast cancer.
- •With axillary lymph node with thickened cortex.
- •Planned for sentinel lymph node biopsy or axillary clearance.
排除标准
- •Nodes ultrasonographically normal.
- •Nodes with hilar displacement .
- •Palpable matted nodes.
结局指标
主要结局
Sensitivity of biopsy
时间窗: Immediate after pathological lymph node stage is available
True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA
次要结局
- Adverse effect of surgery(4 weeks after surgery.)
- Sample adequency(Immediate after biopsy specimen is evaluated by pathologists.)
- Specificity(Immediate after pathological lymph node stage is available.)
研究者
Houpu Yang
Principal Investigator
Peking University People's Hospital