Ideal Marker for Targeted Axillary Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Marker migration
研究概览
简要总结
A multicentre prospective comparative study, comparing the use of various markers (magnetic marker Magseed, iodine seed 125I, carbon suspension) for marking a pathological lymph node in patients with breast carcinoma prior to neoadjuvant therapy and subsequent surgical treatment consisting of targeted axillary dissection.
详细描述
There are two basic aims of the study
- Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection.
- Comparison of the number of complications during localizing and detection of individual markers and postoperative complications.
In individual collaborating centers, these markers are commonly used in clinical practice for marking of a pathological lymph node in patients with breast carcinoma. The usual standard of practice and treatment will not be changed in any way; the patients will only be prospectively followed. The study will bring an answer to the question of which marker is the best for marking lymph nodes.
Apart from the basic demographic and other data (patient age, side of the body, size and characteristics of the tumor (typing, grading, staging), type and time of surgery, the incidence of complications during implantation or detection of the marker, number of lymph nodes, complications after surgery, and the final histological findings, also the following outcome measures will be observed:
- depth of marker implantation (measured in mm)
- marker migration (measured in mm)
- success-rate of resection of the marked lymph node - assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker
- time from localizing the pathological lymph node using the marker to surgery (measured n days)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •diagnosis of breast cancer, confirmed with a biopsy
- •indication of neoadjuvant therapy
- •biopsy of pathologically enlarged axillary lymph node and marking of the lymph node using one of the markers before neoadjuvant chemotherapy
- •surgical treatment after neoadjuvant chemotherapy (targeted axillary dissection)
排除标准
- •refusal to participate in the study
- •another treatment protocol, which does not include targeted axillary dissection
结局指标
主要结局
Marker migration
时间窗: During surgery/intervention
Marker migration will be assessed and measured in millimetres
Success-rate of resection of the marked lymph node
时间窗: 1 month
Assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker.
Time from localizing the pathological lymph node using the marker to surgery
时间窗: 1 month
The time from localizing the pathological lymph node using the marker to surgery will be analysed and measured in days
Depth of marker implantation
时间窗: During surgery/intervention
The depth of marker implantation will be assessed and measured in millimetres
次要结局
未报告次要终点