Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione del Piemonte per l'Oncologia
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Endoscopic Nipple-Sparing Mastectomy (E-NSM)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov