Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Success of the principal objectives is qualified as finding one or more radioactive node in zone D
研究概览
简要总结
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.
详细描述
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Indication for formal Axillary Dissection (AD)
- •N0 patient with a large tumor: T3
- •N1 patient
- •N2 patient with axillary imaging showing limited node involvement(1-4N+).
- •Secondary AD after a positive sentinel node ( pN1, pN1(mi))
- •AD after préopérative chemotherapy in a patient initially N+.
- •Age between 18 and 70
- •Signature of the consent form.
- •Patients beneficiary of the Social Security
排除标准
- •N0 patient with an indication of Sentinel Node biopsy
- •N2 patient with axillary imaging showing suspected node involvement >4N+.
- •N3 patient
- •Age over 70
- •Pregnancy
- •Blue dye allergy
- •Mentally deficient patient
结局指标
主要结局
Success of the principal objectives is qualified as finding one or more radioactive node in zone D
时间窗: 1 day
Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein. If all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective
次要结局
- Evaluate the correlation between clinical and histological results(15 days)
- Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node(15 days)
- Evaluate the morbidity associated with Axillary Dissection.(1 year, 2 years and 5 years)