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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Endoscopic Nipple-Sparing Mastectomy (E-NSM)
Procedure/SurgeryEndoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Single-Arm Endoscopic Nipple-Sparing MastectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery
Number of participants in whom the planned endoscopic nipple-sparing mastectomy through a single axillary incision is completed without conversion to an open technique
Time frame
During the index surgical procedure2
Total operative time
Operative time for the endoscopic nipple-sparing mastectomy procedure, measured from skin incision to completion of wound closure
Time frame
During the index surgical procedure3
Negative surgical margin rate
Number of participants with tumor-free surgical margins on final pathological examination of the mastectomy specimen
Time frame
From surgery to final pathology assessment, up to 30 days after surgerySecondary outcomes
1
Length of postoperative hospitalization
Postoperative length of hospital stay, measured as the number of days from the date of surgery to the date of hospital discharge.
Time frame
From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days2
Participants with at least 1 postoperative complication
Number of participants with at least 1 postoperative complication, defined as nipple-areola complex necrosis, mastectomy skin flap necrosis, surgical-site infection, postoperative bleeding/hematoma, seroma requiring aspiration or drainage, or wound dehiscence.
Time frame
From the date of surgery to 3 months after surgery3
Participants with at least 1 major postoperative complication
Number of participants with at least 1 major postoperative complication, defined as any postoperative complication requiring reoperation or rehospitalization, or resulting in implant loss
Time frame
From the date of surgery to 3 months after surgery4
BREAST-Q Satisfaction With Breasts score
Patient-reported satisfaction with breasts assessed using the BREAST-Q Reconstruction Module, Satisfaction With Breasts scale. Scores range from 0 to 100, with higher scores indicating greater satisfaction and a better outcome
Time frame
Baseline (preoperative assessment) and 3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov