A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Nipple Sensation Evaluation (following NAC sparing mastectomy)
研究概览
简要总结
The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast cancer. You have been asked to take part in this study because your treating surgeon feels you are a candidate for skin-sparing mastectomy and because you want breast reconstruction after surgery. Outcomes that will be measured include how much nipple sensation can be kept after surgery; how satisfied you are with how the breast looks after surgery; complication rates; and your quality-of-life.
详细描述
Operative Procedure:
You will have a skin-sparing mastectomy performed with preservation of the NAC. During surgery, the tissue will be tested while you are still under general anesthesia.
The NAC may be removed completely during the surgery if malignant cells are found during the testing done during the surgery or if suspicious cells that are not clearly benign cells are found. This will be up to your doctor. The NAC may also be removed surgically if the primary tumor is found to be located less than an inch from the border of the NAC, or you are found to have breast cancer with multiple "center" sites. The nipple can also be removed by itself, with the areola spared (this is called "areolar-sparing mastectomy") if your doctor is worried about its blood supply. These decisions will be made by your pathologist and treating surgeon.
You will then undergo immediate reconstruction, with either your own tissue, prosthetic tissue, or a combination of the two. This is up to your plastic surgeon. You will have met with your plastic surgeon before surgery to discuss the best reconstructive method for you, and you will be given an informed consent to sign at that time with details about the method you decide to use.
The breast tissue under the NAC will be biopsied and tested after your surgery. After that tissue has been tested, a second surgery may be needed if cancer cells are found, the tumor is too close to the NAC, or it has more than 1 "center" site. You will have the whole NAC removed in a separate operation. The place where the NAC was removed will be repaired by a plastic surgeon, who will choose the best method to get an acceptable cosmetic result. This may involve one or more extra surgeries, and you will be given separate informed consent documents to sign for each surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients desiring prophylactic mastectomy with immediate reconstruction
- •Patients with Stage 0, I, or II breast cancer who are candidates for and desire skin-sparing mastectomy with immediate reconstruction
- •Tumor location greater than or equal to 2.5 cm from the border of the NAC based on preoperative imaging and/or clinical exam
- •Patients must sign an informed consent and be registered before the procedure is performed
排除标准
- •Patients with cancer involvement of the NAC on clinical exam, defined as induration, retraction, fixation, ulceration, or pathologic nipple discharge
- •Patients with subareolar tumor locations, tumors located < 2.5 cm from the border of the NAC
- •Patients with Paget's disease of the nipple
- •Patients who have locally advanced breast cancer manifesting as inflammatory breast cancer or gross involvement of the mastectomy skin
- •Patients with history of prior surgery involving a periareolar incision
- •Patients desiring a concomitant ipsilateral reduction mammoplasty at time of mastectomy
- •Patients with macromastia as defined by the plastic surgeon
- •Patients with a body mass index (BMI) greater than 40 kg/m2
- •Patients who actively smoke
- •Patients with known collagen vascular disease
- •Patients with prior ipsilateral chest wall irradiation less than 12 months from their time of surgery
结局指标
主要结局
Nipple Sensation Evaluation (following NAC sparing mastectomy)
时间窗: Within first month postoperatively, then at 3 months, 6 month, 1 year, 2 years, and 5 years postoperatively (each interval +/- 1 month)
次要结局
未报告次要终点