NCT03737266已完成不适用
Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- R0 resection rate
研究概览
简要总结
Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 to 80 years
- •Presurgical validated breast cancer
- •Unifocal to multifocal findings
- •Palpable and/o non-palpable findings
- •Neoadjuvant chemotherapy
- •Indication for breast conserving therapy
- •General operation ability and anesthesia ability
- •Consent to conventional breast conserving breast surgery with wire marking
- •Ability and will to follow the study conditions
- •Written declaration of consent after clarification
排除标准
- •Sonographically not clearly delineate resection areal
- •Exclusion criteria for breast conserving therapy
- •Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion
结局指标
主要结局
R0 resection rate
时间窗: 3 years
proportion of surgical procedures for cancer in which the surgeon is able to completely remove all detectable tumor tissue with negative margins, indicating that no cancer cells remain in the surgical site
次要结局
- Weight of primary resedate(3 years)
- Time for cut and sew(During surgery)
研究者
研究点 (2)
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