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Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer

About this study

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

Condition
Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast Cancer
Tested
Endoscopic Nipple-Sparing Mastectomy (E-NSM)
Sponsor
Fondazione del Piemonte per l'Oncologia

Who can join

Age
18 years and older
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Eligible sex: Female
  • Study condition: Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast Cancer
  • 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.
  • Written informed consent provided.

Exclusion 6

  • 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.
  • ASA score 3 or higher.
  • Ongoing pregnancy

Where

1 site, 1 recruiting

Breast Unit

Candiolo, Turin, Italy

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.