The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Recurrence of areolar area
研究概览
简要总结
To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of Areola Sparing Mastectomy.
详细描述
Primary breast cancer originated from areolae is rare. We hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer. Areola Sparing Mastectomy (ASM) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.
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
- •Histologically confirmed invasive or in situ breast cancer.
- •cTis-2N0-1M
- •Indicated for total mastectomy and desire immediate breast reconstruction.
排除标准
- •cT3-4 or cN2-N3 breast cancer.
- •Retraction of nipple or areola.
- •Involvement of subcutaneous layer by cancer on ultrasound or MRI.
研究组 & 干预措施
Areola sparing mastectomy.
Eligible patients undergo areola sparing mastectomy.
干预措施: Areola Sparing Mastectomy (Procedure)
结局指标
主要结局
Recurrence of areolar area
时间窗: Five years after initial surgery
The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.
次要结局
- Cosmetic effect of reconstructed breast(2-4 weeks after surgery; 2 years and 5 years after surgery.)
- Disease free survival(5 year after surgery)
- Adverse effect of surgery(4 weeks after surgery.)
研究者
Houpu Yang
Principal Investigator
Peking University People's Hospital