Identification and Preservation of Arm Lymphatics (DEPART) in Axillary Dissection for Breast Cancer to Reduce Arm Lymphedema Events: A Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Rate of arm lymphedema
研究概览
简要总结
Controversy in axillary reverse mapping in axillary lymph node dissection (ALND) possibly results from incomplete recognition of the arm lymphatic system (ALS) and its compromise to oncological safety. The iDEntification and Preservation of ARm lymphaTics (DEPART) technique facilitates complete identification of ALS; therefore, its use may decrease the occurrence of arm lymphedema. This study aimed to examine the arm lymphedema rate, locoregional recurrence, and feasibility to perform DEPART in ALND.
In the study group, indocyanine green and methylene blue (MB) were utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive. Arm lymphedema, local recurrence, regional recurrence, and distant metastasis were recorded at different follow-up examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older with T1-3 invasive breast cancer;
- •Clinically node-positive breast cancer, defined as positive on preoperative axillary palpation, ultrasound examination, and computed tomography scan with contrast;
- •Patients who underwent mastectomy with a positive sentinel lymph node (SLN);
- •Patients who underwent breast-conserving surgery containing more than two positive SLNs.
排除标准
- •Neoadjuvant chemotherapy;
- •Previous history of breast cancer.
结局指标
主要结局
Rate of arm lymphedema
时间窗: Up to 2 years
A difference in volume between the arms \< 10% was defined as lymphedema.
次要结局
- Rate of distant metastasis(5-year estimate reported after a median follow-up of 60 months)
- Rate of locoregional recurrence(5-year estimate reported after a median follow-up of 60 months)
研究者
Gaosong Wu, Ph D, MD
Chair, Department of Thyroid and Breast Surgery, Zhongnan Hospital of Wuhan University
Wuhan University