This is a single-arm and single-center clinical study. The specific implementation steps of the study are as follows:
1. Patient recruitment and screening Recruit eligible patients through channels such as the breast surgery outpatient department of the hospital. Conduct a preliminary assessment of potential patients, including medical history inquiry, physical examination, and imaging examinations (breast ultrasound, mammography, etc.), to determine whether they meet the inclusion criteria. Adopt the Common Decision Questionnaire (SDM-Q-9).
Evaluate the patients and select those with better compliance and a standardized total score of the scale ≥80. Introduce in detail the research purpose, methods, risks and benefits, etc. to the patients who meet the inclusion criteria and the assessment, and obtain the written informed consent forms of the patients.
2. VAE surgery Ultrasound-guided vacuum-assisted resection: Place the patient in an appropriate position, and use a routine disinfection towel. Locate the tumor location by ultrasound. After local anesthesia, percutaneously puncture a vacuum-assisted rotary cutting needle beneath the tumor. Under ultrasound guidance, gradually remove the tumor tissue until the ultrasound shows that the tumor is completely resected. Send the resected tissue for pathological examination.
3. Follow-up surgery After the patient is confirmed to have breast cancer through VAE resection biopsy, according to the specific condition of the patient, perform radical mastectomy for breast cancer in the hospital. The surgical methods can be breast-conserving surgery or mastectomy. At the same time, perform sentinel lymph node biopsy, and send the resected tissue for pathological examination. The surgical process follows the procedures for breast cancer surgical treatment norms.
4. Postoperative assessment Pathological assessment: Conduct a detailed pathological examination on the specimens removed by vacuum-assisted resection and subsequent surgical resection, including tumor size, histological grade, molecular typing, resection margin conditions, and tumor residue conditions, etc.
Complication assessment: Observe whether complications such as bleeding, infection, breast tissue injury, poor incision healing, and lymphatic leakage occur in patients during vacuum-assisted resection and subsequent surgeries. Record the occurrence time, severity, and treatment measures of complications. Evaluation of surgical satisfaction, treatment satisfaction and quality of life satisfaction: After the operation, give chemotherapy, targeted therapy or endocrine therapy according to the diagnosis and treatment routine. The treatment plan follows the recommendations of guidelines such as NCCN. If local radiotherapy is required, carry it out according to the clinical routine. At 1 week, 1 month, 3 months and 6 months after the operation at time points such as months, evaluate the surgical satisfaction, treatment satisfaction and quality of life satisfaction of the patients.
5. Establish a database for follow-up Utilize the existing breast cancer database of the department to establish individual information data for patients, recording their general information, diagnosis and treatment processes, and other data.
