Minimal accessory-incision-assisted endoscopic breast-conserving surgeryConventional open breast-conserving surgery
Minimal accessory-incision-assisted endoscopic breast-conserving surgery: A small incision was made in the concealed area of the armpit, and a endoscopic device was inserted. Under direct vision, the tumor was precisely removed and the lymph nodes in the armpit were cleared layer by layer. The incision was then sutured layer by layer, and a drainage tube was placed after the operation.
Conventional open breast-conserving surgery: Conventional open breast-conserving surgery is a surgical approach that aims to preserve the appearance and function of the breast as much as possible while ensuring the complete removal of the tumor. It is suitable for eligible patients with early-stage breast cancer and requires comprehensive postoperative treatment measures such as radiotherapy.
Study summary
This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival) between patients undergoing M-E-BCS and patients undergoing C-O-BCS.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* female patients aged 18-70 years (inclusive);
* preoperative pathological examination confirmed it as invasive breast cancer or ductal carcinoma in situ;
* both clinical and imaging examinations clearly indicated that the lesion was a single lesion confined within the gland, without invasion of the skin, subcutaneous tissue, pectoralis major muscle, or the nipple-areola complex;
* tumors in the inner and outer quadrants (three classification method, as shown in Figure 2);
* preoperative tumor size ≤3 cm (pre-neoadjuvant chemotherapy if applicable);
* the tumor is more than 2 cm away from the nipple (the distance is based on physical examination, with MRI and ultrasound as supplementary methods);
* the patient has a clear intention to preserve the breast and can receive standard radiotherapy after the operation;
* voluntary provision of informed consent. .
Exclusion Criteria:
* clinically or radiologically evaluated as multifocal or multicentric breast cancer, with diffuse suspicious calcification, long spiculated masses, extensive local resection unable to obtain sufficient negative margins or ideal shape;
* persistent positive tumor margins, and resection cannot ensure negative margins after resection;
* inflammatory breast cancer;
* pregnant and lactating women;
* previous history of breast cancer surgery (including patients with recurrence after ipsilateral breast-conserving surgery);
* breast cancer genetic gene mutations (such as BRCA1/2 gene mutations);
* preoperative severe underlying diseases that cannot tolerate general anesthesia and surgical procedures.
* other situations that the researchers consider unsuitable for participation
Primary outcome measure(s)
Local recurrence rates — Postoperative 5 years The risk of local recurrence within five years.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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