Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Breast Conserving Surgery for Breast Tumor
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
研究概览
简要总结
The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.
详细描述
A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •with invasive ductal carcinoma of the breast according to core-needle
- •tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
- •located at least 10 mm from the skin surface and chest wall.
排除标准
- •women who were pregnant or breastfeeding
- •radiologic suspicion of multifocality or extensive intraductal carcinoma
- •histologic diagnosis of lobular carcinoma
- •neoadjuvant therapy
- •previous surgery or radiation therapy of the ipsilateral breast.
结局指标
主要结局
overall survival：Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
时间窗: 5 years
Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death)
cosmetic satisfaction：Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
时间窗: 3 years
Patients are rated whether they are satisfied with the surgical scars（bad / moderate /good / very good）
次要结局
- local tumor progress：Defined as the proportion of patients with active tumor at the edge of the treatment ：Defined as the proportion of patients with active tumor at the edge of the treatment(5 years)
- metastasis：Defined as the proportion of cases with metastasis from the beginning of the study to the end of the study or the death of the patient(5 years)
- complication：Defined as numbers of participants with side effect and major complications to the end of the study or the death of the patient(5 years)
研究者
Ping Liang
Director, Clinical Professor
Chinese PLA General Hospital