Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Margin involvement
研究概览
简要总结
The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.
详细描述
Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomization will be performed by another investigator outside the operating room after lumpectomy.
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
- •Breast-conserving surgery.
- •Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
- •Pathological diagnosis of carcinoma in situ or infiltrating
- •Oncoplastic without associated flaps;
排除标准
- •Male patients;
- •Patients with a history of ipsilateral breast cancer.
- •Oncoplastic that includes flaps
- •Multifocality or multicentricity;
- •Pregnant or lactating patient;
- •Stage IV patients;
- •Patients eligible for mastectomy;
研究组 & 干预措施
No Shaving
Standard lumpectomy
干预措施: Margin shaving (Procedure)
Shaving
Subsequent to lumpectomy, a circumferential enlargement of all lumpectomy margins, including lateral, medial, superior, inferior, anterior, and posterior, approximately 5-10mm thick, will be resected.
干预措施: Margin shaving (Procedure)
结局指标
主要结局
Margin involvement
时间窗: 3 weeks after each surgery
To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving
Re-interventions
时间窗: 3 weeks after each surgery
Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
次要结局
- Shaving versus intraoperative pathological study(3 weeks after each surgery)
研究者
Amparo Garcia-Tejedor
Clinical Professor
Hospital Universitari de Bellvitge