The aim of this clinical trial is to assess the feasibility and safety of ultrasound-guided vacuum-assisted excision (VAE) in the treatment of early breast cancer with Tis (carcinoma in situ) or T1 (maximum tumor diameter ≤2cm) and negative axillary lymph nodes on imaging. The main question it aims to answer is:
* After VAE, when undergoing routine breast cancer surgery again, what is the complete resection rate of the lesion in the surgically removed tissue (pathologically confirmed), that is, the false negative rate of VAE? * Which type of breast cancer lesion has the highest complete resection rate? * Is it clear whether VAE can be applied in the treatment of early breast cancer with Tis or T1 and negative axillary lymph nodes on imaging? * Do patients with benign breast nodules who undergo VAE or are recommended for Vacuum-assisted breast biopsy (VABB) due to limited puncture and are diagnosed with breast cancer need to undergo surgery again? * The incidence of complications of VAE.
Participants will:
* Single early breast cancer subjects with Tis or T1 and negative axillary lymph nodes on imaging, after being fully informed and signing the informed consent form, enter the trial period after screening and being qualified. * After the subjects are confirmed to be enrolled, VAE biopsy resection is performed first. * Patients clearly diagnosed with breast cancer receive traditional radical mastectomy for breast cancer: Breast-conserving surgery or total mastectomy, sentinel lymph node biopsy or dissection in the axilla, assessment of whether the lesion has been completely removed based on postoperative pathology, and follow-up is conducted.
Age: 18 - 70 years old;
Female patients;
Patients diagnosed with suspected breast cancer through imaging (such as breast ultrasound, mammography, etc.) with BI - RADS Category 4C and Category 5;
Clinical stage T1: Mass ≤2cm;
Imaging suggests that the lesion is greater than 2cm;
Suspected positive axillary lymph nodes in imaging (Bedi 4, Bedi 5, Bedi 6);
The tumor invades the nipples, areolas and subcutaneous tissues;
Breast cancer during pregnancy;
Single group
Ultrasound-guided vacuum-assisted excision combined with surgical treatment
Procedure/SurgeryPatients undergoing VAE surgery （EnCor® vacuum-assisted minimally invasive rotary system）are placed in an appropriate position, undergo routine disinfection and blanching, and the tumor location is located by ultrasound. After local anesthesia, a vacuum-assisted rotary cutting needle is percutaneous punctured beneath the tumor. Under ultrasound guidance, the tumor tissue is gradually resected until the ultrasound shows complete tumor resection. The resected tissue is sent for pathological examination. After the patient is confirmed to have breast cancer through VAE resection biopsy, depending on the patient's specific condition, they are hospitalized for radical mastectomy. The surgical methods can be breast-conserving surgery or mastectomy. At the same time, sentinel lymph node biopsy is performed, and the resected tissue is sent for pathological examination. The surgical process follows the surgical treatment norms for breast cancer.
The complete resection rate of the lesion in the surgically resected tissue after vacuum-assisted excision under ultrasound guidance
The proportion of patients whose tumor tissues are completely resected by VAE confirmed through postoperative pathological examination, that is, the false negative rate of VAE
Incidence of surgery-related complications
The occurrence of complications such as bleeding, infection, breast tissue injury, poor incision healing and lymphatic leakage during VAE and subsequent surgical procedures
The local recurrence rate of the breast and axilla
The patients are followed up to evaluate whether there is recurrence of breast and axillary lesions
Patient satisfaction
The BREAST Q2 questionnaire is used for the investigation
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