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Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer

RECRUITINGN/ASponsored by Fondazione del Piemonte per l'Oncologia
Actively Recruiting
PhaseN/A
SponsorFondazione del Piemonte per l'Oncologia
Started2025-06-11
Est. completion2026-06-30
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* Female participants aged 18 years or older.
* Diagnosis of early-stage invasive breast cancer or ductal carcinoma in situ, including multifocal or multicentric disease.
* Candidate for nipple-sparing mastectomy with immediate direct-to-implant reconstruction.
* Small- to medium-sized breasts with ptosis grade 2 or less.
* Written informed consent provided.

Exclusion Criteria:

* Preoperative evidence of skin involvement, nipple-areola complex involvement, lymph-node metastases, inflammatory breast cancer, Paget's disease, mesenchymal breast tumors, or recurrent breast cancer.
* Previous ipsilateral breast surgery.
* Previous thoracic radiation therapy.
* Heavy smoking (\>20 cigarettes/day), uncontrolled diabetes mellitus, or body mass index \>30.
* ASA score 3 or higher.
* Ongoing pregnancy

Conditions3

Breast CancerBreast Cancer - Ductal Carcinoma in Situ (DCIS)Cancer

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