Breast Cancer
Conditions
Interventions
Conventional Nipple-sparing mastectomy Surgery Group:Conventional Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
Endoscopic Nipple-sparing mastectomy Surgery Group:Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 to 70 years; 2. Unilateral breast cancer confirmed by preoperative pathology; 3. Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction; 4. Invasive carcinoma with a maximum tumor diameter = 1 cm between the lesion and the nipple-areola complex (NAC); 6. No clinical, radiological, or pathological evidence of tumor invasion into the NAC, skin, or pectoralis major muscle. The tumor must be confined within the glandular tissue; 7. No evidence of distant metastasis (M0); 8. Clinically node-negative (cN0) as assessed by preoperative examinatio; 9. No history of neoadjuvant chemotherapy or radiotherapy prior to surgery; 10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 11. Willing and able to understand the study procedures, provide written informed consent, demonstrate good compliance, and agree to participate in follow-up evaluations; 12. The principal surgeon must have experience in performing at least 30 cases of NSM combined with implant-based reconstruction.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy; 2. Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle. 3. Pregnancy or lactation at the time of enrollment; 4. Requirement for re-excision following a prior breast lump biopsy, or a history of any previous breast surgery (including but not limited to augmentation mammoplasty, breast reduction, lumpectomy, etc.); 5. Breast size exceeding a D-cup; 6. Body mass index (BMI) > 30 kg/m²; 7. Grade III ptosis (severe breast drooping where the nipple is positioned below the inframammary fold); 8. Pre-existing nipple-areolar complex deformities (e.g., nipple inversion, areolar hypoplasia), active skin conditions of the breast (e.g., eczema, dermatitis, infection, ulceration), or significant scarring compromising the surgical site; 9. Severe systemic comorbidities (e.g., immunosuppression, uncontrolled diabetes mellitus, severe cardiopulmonary dysfunction, coagulopathy or bleeding diathesis, contraindications to general anesthesia); 10. Known hypersensitivity or allergy to silicone gel implants, or to anesthetic agents/antibiotics used perioperatively; 11. Pre-existing neurological disorders (e.g., diabetic peripheral neuropathy, Parkinson's disease, polyneuritis, spinal cord injury) or chronic use of medications known to affect neurological/sensory function (e.g., antidepressants, antiepileptics); 12. Current heavy smoking (>20 cigarettes per day); 13. Current alcohol abuse or substance addiction; 14. Concurrent or history of other active malignancies; 15. Anticipated poor compliance with follow-up protocols or inability to complete scheduled postoperative evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 6 months post?operatively, the mean skin sensation threshold in the nine breast zones of the conventional surgery group and the endoscopic surgery group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Longer-term breast aesthetic scores after breast reconstruction;Breast aesthetic scores at 6 months and 1 year after breast reconstruction;Incidence of complications within 1 year after surgery;Longer-term incidence of complications after surgery;Patient quality of life scores assessed at 6 months and 1 year postoperatively;Longer-term patient quality of life scores postoperatively;Longer-term breast skin sensation thresholds in the nine breast zones of the conventional surgery group and the endoscopic surgery group; | — |
Countries
China
Contacts
Public ContactWenbin Zhou
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed