Clinical Impacts of Margin Assessment and Aesthetic Outcomes of Endoscopic Breast Conserving Surgery With Intra-operative Navigation System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Final Margin Assessment
研究概览
简要总结
A growing number of Chinese breast cancer patients are diagnosed at a young age. The quality of life of young breast cancer patients has been a critical issue. Breast-conserving surgery (BCS) not only removes the tumor but also maintains the appearance of breast. The Breast Tumor Center of Sun Yat-sen Memorial Hospital is one of the first departments in China to perform breast-conserving surgeries. Endoscopic breast surgery has emerged as a promising surgical approach. However, it is hard to delineate the tumor margins in endoscopic BCS, which restrains its development. In traditional BCS, surgeons determine the tumor border by palpation, which is impossible in endoscopic BCS. For the first time, we performed the intra-operative navigation system-assisted endoscopic breast-conserving surgery, in which the tumor border was accurately delineated using the navigation system.
详细描述
In the study, patients who are female aged between 18 and 70 years, are pathologically diagnosed operable breast cancer, have proper the important organ functions and adjust to the criteria of endoscopic breast conserving surgery. Intraoperative and post-operatitive Margin Assessment will be the primary outcome measure, and aesthetic outcomes, reoperation rate, as well as patients' feedback will be the secondary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent.
- •Female aged between 18 and 70 years.
- •Pathologically diagnosed operable breast cancer.
- •The important organ functions meet the following criteria:
- •WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;
- •Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN;
- •Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min;
- •Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal);LVEF basement >= 50%.
- •Adjust to the criteria of endoscopic breast conserving surgery.
排除标准
- •Multifocal or multicentric disease.
- •Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
- •Women in the early or intermediate stage of pregnancy;
- •Prior history of breast radiation;
- •Any severe comorbidities, inability to give informed consent or unavailability for follow-up.
结局指标
主要结局
Final Margin Assessment
时间窗: two weeks to one month
Pathological results of the margins. Negative margins are defined as "no ink on tumor". Positive marginsare defined according to the Society of Surgical Oncology consensus guidelines as ink on tumor for invasive cancer with or without DCIS component or cancer cells present within 2mm from the inked surface for pure DCIS.
次要结局
- Reoperation Rate(one month)
- ABNSW system (Aesthetic Outcome)(half a year to one year)
- Patients' Feedback(half a year to one year)
研究者
Shicheng Su
Director of Shuhua Breast Cancer Research Center of Sun Yat- sen Memorial Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University