Oncologic Safety and Aesthetic Outcomes of Areola Preservation With Simultaneous Nipple Reconstruction in Nipple-Sparing Mastectomy With Intraoperative Nipple Involvement: A Single-Center, Prospective, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Local Recurrence Rate
研究概览
简要总结
Background:
During nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.
Purpose:
This is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery.
Study Plan:
This is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group:
The nipple is removed.
A small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved.
A new nipple is created during the same operation using a local skin flap technique (purse-string suture).
All patients will have immediate breast reconstruction.
We plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications.
What We Will Measure (Exploratory Endpoints):
Safety & Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis).
Early Effectiveness: The rate of cancer returning in the breast/chest wall area within 3 years (local recurrence).
Patient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery.
Why This Study is Important:
This is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.
详细描述
This study evaluates the oncological safety and aesthetic outcomes of areola preservation with simultaneous nipple reconstruction in breast cancer patients undergoing nipple-sparing mastectomy who have nipple involvement but negative areolar margins on intraoperative frozen section. The intervention involves removing the nipple while preserving the areolar skin flap and performing immediate nipple reconstruction using a purse-string suture technique. This single-arm, prospective, exploratory study will enroll 45 patients. Primary outcome is technical success rate; secondary outcomes include 3-year local recurrence, complications, BREAST-Q scores, and nipple projection maintenance.
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
盲法说明
This is an open-label surgical study where masking of the participant and surgeon is not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age ≥ 18 years.
- •Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS).
- •Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition).
- •Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction.
- •Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS.
- •ECOG performance status 0-
- •Willing and voluntarily provide written informed consent.
排除标准
- •Clinical or radiological suspicion of areola or skin involvement.
- •Inflammatory breast cancer.
- •Pregnancy or lactation.
- •Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance.
- •Severe uncontrolled comorbidities with a life expectancy of less than 5 years.
研究组 & 干预措施
Areola Preservation & Nipple Reconstruction Group
Patients with intraoperatively confirmed nipple involvement during nipple-sparing mastectomy, who receive areola-preserving surgery (pending negative second frozen section of the peri-areolar margin) combined with immediate nipple reconstruction via a local flap technique (e.g., purse-string suture), followed by immediate breast reconstruction.
干预措施: Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction (Procedure)
结局指标
主要结局
Local Recurrence Rate
时间窗: 3 years post-surgery
The incidence of local recurrence in the ipsilateral chest wall/skin or residual breast tissue, assessed by clinical examination and imaging (breast ultrasound and/or MRI), with pathological confirmation for suspected cases.
次要结局
- Rate of Successful Areola Preservation(Intraoperative)
- Incidence of Postoperative Complications(Within 90 days post-surgery)
- Change in Patient-Reported Satisfaction and Well-being(Baseline, 6, 12, 24, and 36 months post-surgery)