Evaluation of Targeted Axillary Lymph Nodes Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
研究概览
简要总结
evaluation of targeted axillary lymph node dissection in node positive breast cancer patients post neo adjuvant therapy
详细描述
Targeted axillary dissection (TAD) is a novel technique in the field of surgical oncology. During TAD, patients with node-positive breast cancer who clinically responded to neoadjuvant chemotherapy undergo resection of a previously proven metastatic node together with sentinel lymph node dissection (SLND).
Compared to sentinel lymph node dissection (SLND), axillary lymph node dissection [ALND] is associated with increased morbidity, higher rates of lymphedema, paraesthesia, sensory loss in the arm, and impairment in shoulder function. Patients undergoing SLND have fewer infections and a better quality of life, so axillary dissection has been largely replaced by SLND in early-stage breast cancer.
Targeted axillary dissection (TAD) is an innovative surgical procedure that emerged in an attempt to further decrease the false negative results of SLND.
Breast cancer patients suitable for neoadjuvant systemic therapy [NAST] with node-positive disease (N1,N2) were assessed by the multi-disciplinary team and if potentially eligible for TAD, a metallic marker[clip] is inserted in the suspicious node prior to neoadjuvant therapy.
The procedure is performed together with SLND using a single-tracer technique. Towards the end of NAST, a progress ultrasound and mammogram are performed to assess the breast and axillary response, Clip position within node is confirmed.
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
- 15 Years 至 70 Years(Child, Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •females with invasive breast cancer with axillary metastasis, staging of n1: n2
- •complete axillary response to neoadjuvant therapy by clinical examination and imaging
排除标准
- •breast cancer patients who are not candidate for neoadjuvant chemotherapy
- •breast cancer patients with positive axillary node post neoadjuvant chemotherapy
- •breast cancer patients with distant metastasis
- •patients with axillary lymph node metastasis from another primary tumour [not breast cancer]
结局指标
主要结局
Evaluation the sensitivity of targeted axillary lymph node dissection in node positive breast cancer patients
时间窗: 3 monthes
Comparing sensetivity of targeted axillary dissection with traditional SLND
时间窗: 3 monthes
次要结局
- Post operative complications: number of patients with arm lymphedema and sensory loss(3 monthes)
研究者
Omar Abdelnasser Mahmoud Ali
Resident doctor /Omar abdelnasser Mahmoud
Assiut University
