Endoscopic Video-Assisted Nipple-Sparing Mastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
Procedure/SurgeryEndoscopic 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of completion of the procedure endoscopically without conversion to open surgery.
Number of procedure not converted to open surgery on the total of study procedures.
Time frame
At surgery2
Surgery time
Average and median duration of endoscopic dissection, including creation of the working space.
Time frame
At surgery3
Feasibility of immediate reconstruction
The feasibility and type of immediate reconstruction performed (direct-to-implant or two stage) measured as the number immediate rescotruction on the number of total surgery performed.
Time frame
At surgerySponsors and contacts
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Source ClinicalTrials.gov