Intraoperative Nomogram to Predict Breast Cancer- Related Lymphedema Based in Artificial Intelligence Image Recognition: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of distant metastasis
研究概览
简要总结
It has been hypothesized that damaged arm lymphatic drainage is associated with the arm lymphedema after axillary lymph node dissection (ALND). However, the majority of breast cancer patients with complete ALND has not suffered from arm lymphedema, which appears to be due to the residual arm lymph nodes that has not been removed in the axillary dissection. With the compensation of the residual arm lymph flow above the level of axillary vein, the arm lymphatic drainage could keep balance and remain normal function.
This arm lymphedema prediction model that included the protective factor, the proportion of arm lymph flow above the level of axillary vein, allows intraoperative intervention to be performed for the high-risk group. The arm lymphatics of these distinguished patients would be preserved to eliminate the occurrence of arm lymphedema in this study.
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 distant metastasis
时间窗: Up to 5 years
Cancer cells from breast metastasized to other organs.
Rate of arm lymphedema
时间窗: Up to 5 years
A difference in volume between the arms \< 10% was defined as lymphedema
Rate of locoregional recurrence
时间窗: Up to 5 years
Locoregional recurrence included local recurrence and regional recurrence. Local recurrence was defined as chest wall recurrence of breast cancer, and regional recurrence was defined as the axilla recurrence of breast cancer
次要结局
未报告次要终点
研究者
Gaosong Wu, Ph D, MD
Director
Wuhan University