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

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

ClinicalTrials.gov IDNCT07507890

PhaseNA

Enrollment10

SponsorFondazione del Piemonte per l'Oncologia

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Procedure: Endoscopic Nipple-Sparing Mastectomy (E-NSM) — Endoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.

Primary outcomes

Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery (During the index surgical procedure)
Total operative time (During the index surgical procedure)
Negative surgical margin rate (From surgery to final pathology assessment, up to 30 days after surgery)

Eligibility information

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

Study locations

Breast Unit, Candiolo, Turin 10060 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.