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临床试验/CTRI/2019/05/019347
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

发起方
All India Institute of Medical Sciences Delhi
申办方类型
Research institution and hospital

研究点 (1)

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