Areola Preservation in NSM With Nipple Involvement

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Procedure Areola-Preserving Nipple-Sparing Mastectomy with Immediate Nipple Reconstruction
  This is a combined surgical procedure for patients with intraoperative nipple involvement during nipple-sparing mastectomy. After resection of the involved nipple, a full-thickness peri-areolar tissue margin is harvested for a second intraoperative frozen section. If the margin is negative for carcinoma, the areola skin is preserved. An immediate nipple reconstruction is then performed using a local skin flap technique (e.g., purse-string suture). This is followed by standard immediate breast re

Primary outcome measures

• Local Recurrence Rate [Time frame: 3 years post-surgery]

Secondary outcome measures (3)

• Rate of Successful Areola Preservation [Time frame: Intraoperative]
• Incidence of Postoperative Complications [Time frame: Within 90 days post-surgery]
• Change in Patient-Reported Satisfaction and Well-being [Time frame: Baseline, 6, 12, 24, and 36 months post-surgery]

Eligibility criteria

Inclusion criteria

• 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 0-1.
• Willing and voluntarily provide written informed consent.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07544134 · APRESERVE-2025-1471

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗