Cavity Shaving in Breast Conserving Surgery With Intraoperative Cavity Margin Assessment: A Single Center,Randomized,Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Positivity rate of CMs by intraoperative frozen section analysis.
研究概览
简要总结
This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS) on pathological cavity margin (CM) status in breast cancer patients. Patients receiving standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment versus intra-operative CS followed by CM assessment. The primary objective of this study is to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate, post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time and medical costs.
详细描述
After stratified and blocked randomization, the patients' name, admission ID and treatment assignment will be written on a slip of paper, and will be placed in a sealed envelop. A label with the patients' name and admission ID will be placed on the sealed envelop, which will be kept in a locked file. On the day of surgery, a research coordinator will bring the sealed envelope to the operation room. During the standard-of-care BCS, the tumor was excised with a rim of grossly normal tissue. Additional resections are allowed when any of the margins of the tumor-containing specimen were suspected to be inadequate on the basis of standard gross evaluation by surgeons. Prior to intra-operative CM assessment, the research co-ordinator will unseal the envelop and determine which procedure has been designated to the patient. The cosmetic outcome and the quality of life will be evaluated at the day of discharge, after completion of radiotherapy and one year by the patient herself, her partner and a research co-ordinator.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and no more than 65 years of age
- •Able to understand and willing to sign an informed consent document
- •Willing and planning to undergo the breast-conserving surgery
排除标准
- •Inflammatory breast cancer
- •Preference for mastectomy instead of breast-conserving surgery
- •Necessity to undergo oncoplastic breast surgery
- •Prior surgical treatment, including ultrasound-guided vacuum-assisted biopsy and excision biopsy.
- •Prior systemic therapy for this diagnosis, including neoadjuvant chemotherapy, neoadjuvant endocrine therapy.
- •History of prior breast/axillary radiation therapy
- •Known metastatic disease
- •Diagnosed as bilateral breast cancer or DCIS
- •History of other malignancy ≤ 5 years previous
- •Preoperation evaluation indicates tumor size>5cm
- •Preoperation evaluation indicates multicenter or multifocal breast cancer(including suspicious calcification on mammography)
- •Undergoing other clinical trials
- •With sever liver disfunction(Child-Pugh C)
- •With sever cardiac insufficiency
- •With sever renal disfunction
- •Pregnancy
结局指标
主要结局
Positivity rate of CMs by intraoperative frozen section analysis.
时间窗: Completion of surgery for all enrolled patients (approximately 12 months)
Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) CMs on intraoperative frozen section analysis
次要结局
- Cost-effectiveness of cavity shaving in BCS as measured by operative time of the surgery(Completion of surgery for all enrolled patients (approximately 12 months))
- Rate of intra-operative re-excision for suspected/positive CMs(Completion of surgery for all enrolled patients (approximately 12 months))
- Intra-operative rate of suspected/positive CM(Completion of surgery for all enrolled patients (approximately 12 months))
- Rate of a second-time surgery for post-operative positive CMs(Completion of surgery for all enrolled patients (approximately 12 months))
- Proportion of patients successfully undergone BCT(Completion of surgery for all enrolled patients (approximately 12 months))
- Adverse events(One year after surgery.)
- Cosmetic outcome(One year after surgery.)
- Quality of life.(One year after surgery.)
- Cost-effectiveness of cavity shaving in BCS as measured by medical cost of the surgery(Completion of surgery for all enrolled patients (approximately 12 months))
研究者
Fengxi Su
Director of the Breast Tumor Department of Sun Yat-Sen Memorial Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University