The Comparison Between M-E-BCS and C-O-BCS.

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.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

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

• RESULTSchumacher JR, Wiener AA, Greenberg CC, Hanlon B, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher JG, Yu M, Vanness DJ, Yang DY, Havlena J, Strand C, Neuman HB. Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01). Ann Surg. 2023 May 1;277(5):841-845. doi: 10.1097/SLA.0000000000005776. Epub 2022 Dec 14. PMID 36521077
• RESULTLiang Y, Xu S. Nonliposuction Endoscopic Sentinel Lymph Node Biopsy Through the Periareolar Incision. Surg Innov. 2020 Dec;27(6):570-579. doi: 10.1177/1553350620942983. Epub 2020 Jul 20. PMID 32687735
• RESULTMok CW, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast. 2019 Aug;46:144-156. doi: 10.1016/j.breast.2019.05.013. Epub 2019 May 20. PMID 31176887
• RESULTPatrianagara A, Hwei LRY. Endoscopy-assisted breast conservation surgery (E-BCS) vs conventional breast conservation surgery (C-BCS) technique for the management of early breast cancer: A systematic review and meta-analysis. Breast Dis. 2023;42(1):383-393. doi: 10.3233/BD-230023. PMID 38108340
• RESULTLai HW, Chen ST, Liao CY, Mok CW, Lin YJ, Chen DR, Kuo SJ. Oncologic Outcome of Endoscopic Assisted Breast Surgery Compared with Conventional Approach in Breast Cancer: An Analysis of 3426 Primary Operable Breast Cancer Patients from Single Institute with and Without Propensity Score Matching. Ann Surg Oncol. 2021 Nov;28(12):7368-7380. doi: 10.1245/s10434-021-09950-8. Epub 2021 May 11. PMID 33974198
• RESULTTakahashi H, Fujii T, Nakagawa S, Inoue Y, Akashi M, Toh U, Iwakuma N, Takahashi R, Takenaka M, Fukuma E, Shirouzu K. Usefulness of endoscopic breast-conserving surgery for breast cancer. Surg Today. 2014 Nov;44(11):2037-44. doi: 10.1007/s00595-013-0767-2. Epub 2013 Oct 24. PMID 24150099