to evaluate the effectiveness and safety of mastectomy combined with immediate breast reconstruction in breast cancer

Conditions: Breast Cancer

Summary: the new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery. however, the new technology of endoscopic-assisted mastectomy and immediate breast reconstruction in china in the treatment of breast cancer is still in the exploratory stage and needs to be further improved. this prospective, single-center, double-arm clinical study was conducted to use the endoscopic-assisted system and evaluate the effectiveness and safety of the mastectomy combined with immediate breast reconstruction in breast cancer.


Eligibility criteria:
inclusion criteria: 1. female patients, aged 18-75 years old; the pregnancy test (-) and reliable contraceptive methods are required for premenopausal and perimenopausal patients; 2. patients with the diagnosed breast cancer confirmed by core needle biopsy and unilateral operation was performed; breast cancer patients with tumor node metastasis stage 0-iii according to the 8th edition of the american joint commission on cancer; preoperative clinical examination or imaging evaluation shows that the distance between the tumor and the nipple areolar complex (nac) is more than 1cm. the tumor has a diameter of 2-3 cm and can be located in any quadrant or reduced to 3 cm through preoperative neoadjuvant chemotherapy. the distance between the lesion and the skin should be at least 8-10 mm; 3. there is no clinical or imaging evidence to prove that the tumor has invaded the skin, chest wall, or nipple areola complex; 4. there are indications for breast preservation, but the patient has a strong desire for reconstruction and is unwilling to undergo breast preservation surgery; 5. preventive mastectomy (brca1/2 malignant mutation with obvious family history of breast cancer and other high-risk groups); 6. preoperative clinical manifestations and imaging data showed no distant metastasis; 7. no history of breast cancer or other serious underlying diseases in the past; 8. karnofsky performance status score ≥ 70; 9. eastern cooperative oncology group score ≤ 2 ; 10. the surgical procedure includes endoscopic-assisted/conventional mastectomy, sentinel lymph node biopsy/axillary lymph node dissection and immediate breast reconstruction; 11. participants are able to understand the research process, voluntarily join the study, sign informed consent forms, have good compliance, and cooperate with follow-up; 12. no swallowing difficulties; no shoulder joint movement disorders; 13. complete clinical data. exclusion criteria: 1. male breast cancer or inflammatory breast cancer; 2. metastatic breast cancer (stage iv); tumor invasion of the skin, pectoralis major muscle, or nac; 3. the clinical data is basically incomplete; 4. previously received chemotherapy in an external hospital or has undergone tumor resection in an external hospital; 5. bilateral breast cancer surgery; 6. other surgical methods; 7. preoperative distant metastasis or supraclavicular lymph node dissection; 8. complicated with other malignant tumors or had malignant tumors other than breast cancer in recent 5 years; 9. the serious disease of non malignant tumors combined will affect the patient's compliance or put the patient in a dangerous state; 10. dementia, intellectual disability, or any mental illness that hinders understanding of informed consent forms.

Keywords: endoscopic-assisted mastectomy and immediate breast reconstruction