Magnetic Seed Localisation for Nonpalpable Breast Lesions: a Combined Retrospective and Prospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Number of participants with positive surgical margins as assessed by pathological examination of the specimen
研究概览
简要总结
Screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. Multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. Specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. Since September 2018, Magseed® localisation is the standard of care for localising impalpable breast lesions in UZ Leuven. In this study, the oncological safety, the clinical safety and surgeon satisfaction of Magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast conserving surgery with preoperative localisation
- •Minimum 18 years old
排除标准
- 未提供
结局指标
主要结局
Number of participants with positive surgical margins as assessed by pathological examination of the specimen
时间窗: Up to three weeks after surgical treatment
Re-operation rate due to positive surgical margins
时间窗: Up to three weeks after surgical treatment
Surgeon satisfaction based on a questionnaire
时间窗: After surgery
After surgery, the surgeon will be asked to describe the magnetic seed procedure, choosing between 'easier than hooked-wire' or 'more challenging than hooked-wire'. Moreover, the surgeon wil have the chance to add additional remarks or experiences with this new technique.
Number of participant with device-related adverse events
时间窗: Up to three weeks after surgical treatment
Total breast volume resected during breast conserving surgery
时间窗: Up to three weeks after surgical treatment
次要结局
未报告次要终点