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

Official title

A Comparative Study of Minimal Accessory-Incision-Assisted Endoscopic Breast-Conserving Surgery With Minimal Auxiliary Incisions Versus Conventional Open Breast-Conserving Surgery: A National Multicenter, Open-Label, Randomized Controlled Trial (MECO-BCS)

Overview

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.

Detailed description

Breast cancer is a highly prevalent malignant tumor among women, and comprehensive treatment mainly based on surgery is the main mode. Breast aesthetics is important, breast-conserving surgery (BCS) is a common surgical approach, which can preserve the breast shape, does not affect subsequent treatment, and has been confirmed to be safe in terms of oncology. Conventional open breast-conserving surgery (C-O-BCS) requires multiple incisions, resulting in prominent scars. With the introduction of minimally invasive techniques, endoscopic breast-conserving surgery (E-BCS) has emerged as an alternative. It reduces the number of incisions, lowers the incidence of complications, and enhances aesthetic outcomes and patient satisfaction, while maintaining similar oncological safety compared to open surgery. However, single-incision E-BCS is limited by restricted operative space, making precise tumor resection and oncoplastic procedures challenging. Although multi-incision E-BCS facilitates surgical procedures, it does not improve scar aesthetics and may increase surgical trauma and costs. As a result, the adoption of endoscopic breast-conserving surgery has been limited, and there is a lack of high-quality clinical studies in this area.

Our team proposed the minimal accessory-incision-assisted endoscopic breast-conserving surgery (M-E-BCS), which has concealed incisions, strong operability, and good cosmetic effects. It is being popularized in China. To comprehensively evaluate its clinical benefits, large-scale multicenter studies are needed to provide evidence-based medical evidence and optimize surgical plans.

Therefore, this national multicenter, open-label, randomized controlled trial will compare outcomes between patients undergoing M-E-BCS versus C-O-BCS. 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).

Interventions

• Procedure 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.
• Procedure 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.

Primary outcome measures

• Local recurrence rates [Time frame: Postoperative 5 years]

Secondary outcome measures (12)

• Surgical efficiency [Time frame: Intraoperative]
• Economic effect [Time frame: 1 month postoperative]
• Surgical safety [Time frame: Intraoperative, 3 months postoperative.]
• Aesthetic outcomes (BREAST-Q score) [Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.]
• Aesthetic outcome (Harris score) [Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.]
• Aesthetic outcome (Ueda score) [Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.]
• Aesthetic outcome (SCAR-Q score) [Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.]
• Surgical margin involvement [Time frame: 2-3 weeks postoperative after paraffin-embedded pathological report available.]
• Resection mastectomy weight [Time frame: Immediate postoperative]
• Local Recurrence-Free Survival(LRFS) [Time frame: 2 years postoperative and 5 years postoperative.]
• Regional Recurrence-Free Survival (RRFS) [Time frame: 2 years postoperative and 5 years postoperative.]
• Distant Metastasis-Free Survival (DMFS) [Time frame: 2 years postoperative and 5 years postoperative.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• West China hospital of Sichuan University — Chengdu

Publications

• Schumacher 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 202 PMID 36521077
• Liang 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
• Mok 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
• Patrianagara 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
• Lai 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
• Takahashi 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
• Ozaki S, Ohara M, Shigematsu H, Sasada T, Emi A, Masumoto N, Kadoya T, Murakami S, Kataoka T, Fujii M, Arihiro K, Okada M. Technical feasibility and cosmetic advantage of hybrid endoscopy-assisted breast-conserving surgery for breast cancer patients. J Laparoendosc Adv Surg Tech A. 2013 Feb;23(2):91-9. doi: 10.1089/lap.2012.0224. Epub 2012 Dec 28. PMID 23272727
• Haloua MH, Krekel NM, Winters HA, Rietveld DH, Meijer S, Bloemers FW, van den Tol MP. A systematic review of oncoplastic breast-conserving surgery: current weaknesses and future prospects. Ann Surg. 2013 Apr;257(4):609-20. doi: 10.1097/SLA.0b013e3182888782. PMID 23470508

Identifiers

NCT: NCT07539545 · 2025(1479)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗