Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Nipple-Sparing Mastectomy (E-NSM).
- Who it may be relevant to
- Registry conditions: Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MINI-B - Minimally Invasive Endoscopic Mastectomy Using a Single Axillary Incision in Breast Cancer Patients: a Prospective Cohort Study
Overview
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
Detailed description
MINI-B is a single-institution prospective study conducted at the Breast Surgery Unit of Candiolo Cancer Center, Istituto di Candiolo FPO-IRCCS, Torino, Italy. The study will enroll 10 consecutive adult female patients with early-stage invasive breast cancer or ductal carcinoma in situ who are candidates for nipple-sparing mastectomy with direct-to-implant reconstruction and are suitable for a minimally invasive approach. The investigated procedure is endoscopic nipple-sparing mastectomy performed through a single hidden axillary incision using a standardized technique modeled on the robotic nipple-sparing mastectomy procedure already in use at the institution. The study will evaluate feasibility through technical and perioperative parameters, assess resection completeness by margin status, record postoperative complications over 3 months, and collect patient-reported quality-of-life data using BREAST-Q/EORTC questionnaires.
Interventions
- Procedure Endoscopic Nipple-Sparing Mastectomy (E-NSM)
Endoscopic 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.
Primary outcome measures
- Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery [Time frame: During the index surgical procedure]
- Total operative time [Time frame: During the index surgical procedure]
- Negative surgical margin rate [Time frame: From surgery to final pathology assessment, up to 30 days after surgery]
Secondary outcome measures (7)
- Length of postoperative hospitalization [Time frame: From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days]
- Participants with at least 1 postoperative complication [Time frame: From the date of surgery to 3 months after surgery]
- Participants with at least 1 major postoperative complication [Time frame: From the date of surgery to 3 months after surgery]
- BREAST-Q Satisfaction With Breasts score [Time frame: Baseline (preoperative assessment) and 3 months after surgery]
- BREAST-Q Reconstruction Module Psychosocial Well-Being score [Time frame: Baseline (preoperative assessment) and 3 months after surgery]
- BREAST-Q Reconstruction Module Physical Well-Being: Chest score [Time frame: Baseline (preoperative assessment) and 3 months after surgery]
- BREAST-Q Reconstruction Module Sexual Well-Being score [Time frame: Baseline (preoperative assessment) and 3 months after surgery]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Breast Unit — Candiolo
Identifiers
NCT: NCT07507890 · 003-FPO25