Endoscopic Video-Assisted Nipple-Sparing Mastectomy
EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study
European Institute of Oncology
10 participants
May 23, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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
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Interventions
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. Recent prospective studies and meta-analyses have shown encouraging results in terms of technical feasibility, reduced flap-related complications, and higher patient satisfaction compared with the conventional open approach.
Locations(1)
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NCT07579117