Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Rate of patients who it is possible preserve ARM nodes
研究概览
简要总结
The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.
详细描述
Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.
In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.
The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.
HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who will undergo ALND in the treatment of breast cancer:
- •cT4a, cT4c and cT4d.
- •cT4b with extensive involvement of the skin.
- •cN0 with SLNB positive (pN+) that need to associate ALND:
- •>2 lymph node macrometastasis if cTis, cT1 and cT
- •Patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy.
- •If primary surgery treatment.
- •After neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or SLNB positive (ypN+).
- •If primary surgery treatment.
- •After neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or HER2 overexpressed tumours.
排除标准
- •Patients with previous axillary surgery (except sentinel node biopsy)
- •Patients who did previous axillary radiotherapy treatment.
- •Patients who do not wish to participate in the study.
研究组 & 干预措施
Axillary mapping reverse
Application of axillary mapping reverse technique
干预措施: Axillary mapping reverse (Procedure)
结局指标
主要结局
Rate of patients who it is possible preserve ARM nodes
时间窗: 1 year
Determinate the percentage of patients who is possible preserve the ARM node during ALND
次要结局
- Rate of metastatic ARM(1 year)
研究者
Amparo Garcia-Tejedor
Principal Investigator
Hospital Universitari de Bellvitge