Ultrasound Guided Percutaneous Microwave Ablation for Breast Lesions: A Prospective Multicenter Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- reduction in volume
研究概览
简要总结
The investigators will perform this study to prospectively analyse the clinical outcome after percutaneous microwave ablation(MWA) of benign and malignant breast lesion under ultrasound (US) guidance.
详细描述
A total of more than 500 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in seven centers of China will be recruited in this study and underwent US-guided percutaneous MWA 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 measured and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •breast lesion proved by using core-needle biopsy;
- •for benign lesions,lesion 1.0 cm or larger in greatest diameter and continually increasing during a half year follow-up; for malignant ones, lesion size 2cm or smaller;
- •distance of at least 1.0cm to papilla with the patients supine;
- •the symptoms of local pain, discomfortable or compression considered probably relating to the lesion of breast;
- •the patient with evidently psychological pressure due to the occurrence of the lesion;
- •patients unwilling or refused to receive other treatment and presence of an appropriate route for percutaneous puncture under US guidance.
排除标准
- •patients who were pregnant or breast-feeding;
- •patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction;
- •patients during menstrual period;
- •patients who wanted to undergo other therapies including surgical excision and vacuum-assisted biopsy.
结局指标
主要结局
reduction in volume
时间窗: 5 year
the volume reduction ratio (VRR) which was calculated by the following equation: VRR (%) = \[(initial volume - final volume) × 100\]/initial volume.
次要结局
未报告次要终点
研究者
Ping Liang
Chair
Chinese PLA General Hospital