Aesthetic Outcomes of Oncoplastic Breast Surgery With a Droplet-Shaped Glandular Flap for Breast Cancer in the Upper Inner Quadrant
试验速览
- 阶段
- 不适用
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- aesthetic outcomes
研究概览
简要总结
Oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. The upper inner quadrant is one of the most difficult and challenging tumor locations for surgeons to perform oncoplastic breast surgery. There is a pressing need to develop a simple and effective oncoplastic surgical technique to cope with the unfavorable anatomy and location of tumors in the UIQ. Here, we present a new oncoplastic volume displacement technique for UIQ using the DSG flap. This trial was design to estimate the aesthetic outcomes of an oncoplastic technique using a droplet-shaped glandular flap for breast cancer in the upper inner quadrant.
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.
- •WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Cancer located in the upper inner quadrant; Single tumor or multiple tumors in the same quadrant.
- •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 breast conserving surgery.
排除标准
- •Multifocal or multicentric disease.
- •Tumor localized in the central quadrant or the distance to the nipple < 2 cm；
- •Diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology.
- •The ratio of tumor to breast > 20%;
- •The diameter of tumor is up to 4 cm;
- •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
aesthetic outcomes
时间窗: half a year to one year
ABNSW system. The total score was 15 points, outcomes were good when it was 11-14, fair when it was 6-10, and poor when it was 0-5.
次要结局
- Local recurrence(half a year to one year)
- Patients complications after surgery(half a year to one year)
- Patients' quality of life(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