Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy
Conditions
Interventions
Test group:Use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction
Control group:Don’t use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18–70 years (inclusive18 and 70 years); 2. Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted; 3. Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy; 4. For non-specialized breast cancer patients, preoperative tumor size <=5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively; 5. Patients volunteered to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy); 2. Breast cancer diagnosed during pregnancy or lactation; 3. Subnipple-plane scarring with radiotherapy; 4. Metastatic breast cancer (M1); 5. Severe comorbidities precluding general anesthesia or surgery; 6. BMI >=40 kg/m²; 7. HbA1c >7.5%; 8. Immunodeficiency; 9. Active smoking with >=20 cigarettes per day; 10. Patients with concurrent participation in conflicting clinical trials;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operative time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local Recurrence-Free Survival(LRFS);Resection mastectomy weight;Overall Survival(OS);Surgical margin involvement;Ueda score;Regional recurrence-free survival (RRFS);Distant metastasis-free survival (DMFS);Complications;BREAST-Q scores;Harris score;Disease-free survival (DFS):; | — |
Countries
China
Contacts
Public ContactZhenggui Du
West China Hospital of Sichuan University
Outcome results
None listed