Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- detective rate of sentinel lymph node
研究概览
简要总结
This study is designed to compare the effectiveness of intradermal injection and subcutaneous injection with methylene blue for early-stage breast cancer patients who need sentinel lymph node biopsy.
详细描述
After fully informing and consent, patients recruited would be randomized 1:1 to intradermal injection group and subcutaneous injection group. Investigators aimed to find out the difference in sentinel lymph nodes detected rate, blue lymphatic detected rate and complication incidence between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •who sign the informed consent form
- •pathological diagnosed, without distant metastasis, early stage invasive breast cancer patients
- •did not undergo neoadjuvant chemotherapy, endocrinotherapy or targeted therapy previously
- •without breast and axillary surgery history
- •Ejection fraction score in normal range accord to cardiac doppler
- •Eastern Cooperative Oncology Group score ≤0-2
- •axillary lymph node clinical negative
排除标准
- •pregnancy
- •any history of malignant tumor within five years
- •diagnosis of multi-center, multi-focal or bilateral breast cancer
- •history of breast tumor incision biopsy or vacuum-assisted biopsy
- •methylene blue allergic
- •appear with severe systematic disease or disfunction of any organ
结局指标
主要结局
detective rate of sentinel lymph node
时间窗: through study completion, an average of 1.5 year
Right after each of the sentinel lymph node biopsy, the investigators would collect data of whether it was successful or not and the amount of sentinel lymph nodes that shown out by the certain intervention.
次要结局
- detective rate of blue lymphatic(through study completion, an average of 1.5 year)
- incidence of adverse events(1 month after surgery)
研究者
Fengxi Su
professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University