A Randomized Controlled Trial of Endoscopic Subcutaneous Mastectomy Versus Open Mastectomy in Early Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- local recurrence rate
研究概览
简要总结
The consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease. Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the nipple-areola complex which facilitates breast reconstruction. However, SM still leaves behind a conspicuous scar.There have already been some observation study show that endoscopic subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe as the traditional SM.However there is no RCT in this field.That is why the investigators design 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of stages I or II ductal carcinoma
- •The distance from the tumor to the edge of the papilla is more than 3cm, the tumor volume is less than 3cm, the axillary lymph nodes have no obvious fusion and no adhesion with the axillary vein and brachial plexus
- •Age from 18~70
- •ECOG scores 0~2
- •Normal function of liver, kidney and bone marrow
排除标准
- •Through physical examination and MRI, it was confirmed that the tumor did not invade the skin, but was confined to the gland and did not invade the surface of the gland.
- •There are serious medical diseases
- •Pregnant or lactating women women of childbearing age -
结局指标
主要结局
local recurrence rate
时间窗: 12 months after operation
Definition and diagnostic criteria of local recurrence: physical examination or imaging examination found lesions in the same side of breast, chest wall or skin and surgical scars, and confirmed by histology as breast cancer of the same tissue type; 12 months after operation, the evaluation was carried out.
次要结局
- Distant metastasis(12 months after operation)
研究者
Zhongtao Zhang
Director of general surgery, principal investigator
Beijing Friendship Hospital