CTRI/2019/05/019347尚未招募不适用
Comparision of wire guided lumpectomy versus sonographic hematoma guided lumpectomy in management of nonpalpable breast cancers
All India Institute of Medical Sciences Delhi1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2019年1月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Reoperation Rates
研究概览
简要总结
Thegoal of breast conservation therapy for breast cancer is to achieve anoncologic resection with adequate margins while maintaining cosmesis. Thisposes significant challenges in the case of nonpalpable lesions and requiresimage-guided localization to effect resection. The current standard techniqueof operative guidance is preoperative wire localization, which is associatedwith several limitations. Smith et al, described the use of the sonographicallyvisible hematoma (induced iatrogenically) as a localizing device with intraoperativeultrasonography. We hypothesized that sonographic hematoma-guided (SHG)lumpectomy for breast cancer is better than wire guided excision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Nonpalpable BIRADS 4 or BIRADS 5 breast lesions 2.All women above the age of 18 years with histopathologically proved nonpalpable breast cancer.
排除标准
- 未提供
结局指标
主要结局
Reoperation Rates
时间窗: 2 years
次要结局
- Cost benefit analysis(Patient satisfaction)
研究者
研究点 (1)
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