Recruiting

Endoscopic Video-Assisted Nipple-Sparing Mastectomy

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.

ClinicalTrials.gov IDNCT07579117

PhaseNA

Enrollment10

SponsorEuropean Institute of Oncology

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Endoscopic Video-assisted Nipple-sparing Mastectomy, Breast Surgery, Breast Cancer

About this study

Interventions

Procedure: Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) — 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.

Primary outcomes

Rate of completion of the procedure endoscopically without conversion to open surgery. (At surgery)
Surgery time (At surgery)
Feasibility of immediate reconstruction (At surgery)

Eligibility information

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

Study locations

Istituto Europeo di Oncologia, Milan, 20141 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.