This study is a multicenter, open-label, randomized controlled trial. The study aims toevaluate 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-BCSand patients undergoing C-O-BCS.
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).
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.
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
West China hospital of Sichuan University
Chengdu, Sichuan, China
Investigator: Zhenggui Du
Contact: +86 13880768222
docduzg@163.com
Zhenggui Du Du
+86 13880768222
docduzg@163.com
Not Provided