Radioguided Occult Lesion Localization (ROLL) is Superior a to the Wire-Guided Lesion Localization (WGLL)? Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 主要终点
- Localization of nonpalpable breast lesion (percentage)
研究概览
简要总结
Here were present a controlled clinical trial comparing wire-guided lesion localization (WGLL)and radioguided occult lesion localization (ROLL) in patients treated for nonpalpable breast lesions at the Instituto Nacional de Cancerología (National Cancer Institute)in Bogotá,Colombia.
详细描述
The aim of this study was to compare the radioguided occult lesion localization (ROLL) technique with the wire-guided lesion localization (WGLL) technique to assess the optimal localization and excision of nonpalpable breast lesions in patients at a unique reference medical center.
A controlled clinical trial was designed to compare the WGLL and ROLL techniques in women presenting with breast lesions diagnosed by mammography or ultrasound at the Instituto Nacional de Cancerología in Bogotá, Colombia from March 2006 to June 2011.
This study evaluate 129 patients; 64 (49.6%) patients were treated using ROLL and 65 (51.4%) using WGLL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients older than 18 years
- •Lesions suggesting malignancy (BIRADS 4 and 5)
- •Solid nodules in postmenopausal women (BIRADS 3 mammograms).
排除标准
- •Pregnant or nursing
- •Patients with suspected multifocal or multicentric disease (suspicious microcalcifications scattered over a wide area on mammography)
- •Patients with retro-areola lesions (less than 2 cm away from the nipple)
- •Lesions that had previously undergone surgery or excisional biopsies in the compromised breast
结局指标
主要结局
Localization of nonpalpable breast lesion (percentage)
时间窗: 30 days
次要结局
- presence of malignancy(30 days)