Breast Cancer, Breast Cancer - Ductal Carcinoma in Situ (DCIS)
Conditions
Keywords
Breast, Endoscopic Nipple-Sparing, Mastectomy, E-NSM
Brief summary
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
PROCEDUREEndoscopic 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.
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All enrolled participants will undergo endoscopic nipple-sparing mastectomy through a single axillary incision with immediate direct-to-implant reconstruction
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery | During the index surgical procedure | Number of participants in whom the planned endoscopic nipple-sparing mastectomy through a single axillary incision is completed without conversion to an open technique |
| Total operative time | During the index surgical procedure | Operative time for the endoscopic nipple-sparing mastectomy procedure, measured from skin incision to completion of wound closure |
| Negative surgical margin rate | From surgery to final pathology assessment, up to 30 days after surgery | Number of participants with tumor-free surgical margins on final pathological examination of the mastectomy specimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of postoperative hospitalization | From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days | Postoperative length of hospital stay, measured as the number of days from the date of surgery to the date of hospital discharge. |
| Participants with at least 1 postoperative complication | From the date of surgery to 3 months after surgery | 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. |
| Participants with at least 1 major postoperative complication | From the date of surgery to 3 months after surgery | Number of participants with at least 1 major postoperative complication, defined as any postoperative complication requiring reoperation or rehospitalization, or resulting in implant loss |
| BREAST-Q Satisfaction With Breasts score | Baseline (preoperative assessment) and 3 months after surgery | 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 |
| BREAST-Q Reconstruction Module Psychosocial Well-Being score | Baseline (preoperative assessment) and 3 months after surgery | Patient-reported psychosocial well-being assessed using the BREAST-Q Reconstruction Module, Psychosocial Well-Being scale. Scores range from 0 to 100, with higher scores indicating better psychosocial well-being |
| BREAST-Q Reconstruction Module Physical Well-Being: Chest score | Baseline (preoperative assessment) and 3 months after surgery | Patient-reported physical well-being of the chest assessed using the BREAST-Q Reconstruction Module, Physical Well-Being: Chest scale. Scores range from 0 to 100, with higher scores indicating better physical well-being |
| BREAST-Q Reconstruction Module Sexual Well-Being score | Baseline (preoperative assessment) and 3 months after surgery | Patient-reported sexual well-being assessed using the BREAST-Q Reconstruction Module, Sexual Well-Being scale. Scores range from 0 to 100, with higher scores indicating better sexual well-being |
Countries
Italy
Contacts
CONTACTAntonio Toesca, MD
CONTACTGiada Pozzi, MD
Outcome results
None listed