Endoscopic Video-Assisted Nipple-Sparing Mastectomy

EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study

Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.

This pilot study aims to prospectively document the technical feasibility and perioperative outcomes of E-NSM performed according to an established institutional protocol, including standardized perfusion assessment using indocyanine green (ICG) angiography and patient-reported outcomes using BREAST-Q questionnaire. Data generated from this study will support refinement of the institutional protocol and inform the design of future comparative or multicentre trials.

Inclusion Criteria:

• Female patients aged ≥18 years
• Candidates for nipple-sparing mastectomy (NSM) with immediate reconstruction
• Histologically confirmed invasive carcinoma cT1N0, or carriers of pathogenic germline mutations undergoing prophylactic mastectomy
• Breast size I-III and absence of significant glandular ptosis
• Signed informed consent

Exclusion Criteria:

• Inflammatory breast cancer
• Locally advanced clinical stage (cT2-T4 or N+)
• Ductal carcinoma in situ (DCIS) without invasive component
• Previous radiotherapy to the affected breast
• Locoregional recurrence
• Clinical conditions contraindicating prosthetic reconstruction
• Indication for skin-sparing (SSM) or skin-reducing mastectomy (SRM)
• Ongoing or completed neoadjuvant chemotherapy before surgery
• Refusal or inability to sign informed consent
• Inability to complete scheduled follow-up