Breast Cancer
Conditions
Keywords
Breast Cancer, Endoscopic surgery, Minimal invasive surgery, Breast-conserving Surgery
Brief 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.
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
PROCEDUREMinimal 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.
PROCEDUREConventional 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.
Sponsors
Du Zhenggui
West China Fourth Hospital of Sichuan University
West China Second University Hospital
The Fourth People's Hospital of Sichuan Province
Taiyuan Central Hospital of Shanxi Medical University
Chengdu Second people's hospital
Suzhou Municipal Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence rates | Postoperative 5 years | The risk of local recurrence within five years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical efficiency | Intraoperative | Total operative time (min) from skin incision to complete closure of incision, the operative time for axillary surgery and the operative time for breast surgery. |
| Economic effect | 1 month postoperative | The total cost from the patient's admission to discharge, the surgery fee and the hospitalization fee (USD). |
| Surgical safety | Intraoperative, 3 months postoperative. | Surgical complication rates, major complication rates and minor complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis. |
| Aesthetic outcomes (BREAST-Q score) | Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative. | The BREAST-Q scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores. |
| Aesthetic outcome (Harris score) | Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative. | The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted). |
| Aesthetic outcome (Ueda score) | Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative. | Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented. |
| Aesthetic outcome (SCAR-Q score) | Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative. | A validated scar-specific patient-reported outcome measure tool for assessing the quality of life of patients with scars. It consists of three independent scales: scar appearance, scar symptoms, and psychosocial impact. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. |
| Surgical margin involvement | 2-3 weeks postoperative after paraffin-embedded pathological report available. | Surgical margin involvement was defined as ink on tumor on postoperative paraffin-embedded pathological examination. |
| Resection mastectomy weight | Immediate postoperative | Mean mastectomy weight (g) |
| Local Recurrence-Free Survival(LRFS) | 2 years postoperative and 5 years postoperative. | The time interval from initiation of treatment to the first recurrence at the primary tumor site. If local recurrence appears, record the time and location of recurrence. |
| Regional Recurrence-Free Survival (RRFS) | 2 years postoperative and 5 years postoperative. | The time from the date of diagnosis or treatment to the date of first regional recurrence (recurrence in the ipsilateral regional lymph nodes, including axillary, internal mammary, or supraclavicular nodes) or death from any cause, whichever occurs first. |
| Distant Metastasis-Free Survival (DMFS) | 2 years postoperative and 5 years postoperative. | The time from the date of diagnosis or treatment to the date of first distant metastasis (spread to distant organs such as bone, lung, liver, or brain) or death from any cause, whichever occurs first. |
| Progression-Free Survival (PFS) | 2 years postoperative and 5 years postoperative. | The time from the date of initiation of systemic therapy (or randomization in clinical trials) to the date of first documented disease progression (either local, regional, or distant recurrence) or death from any cause, whichever occurs first. |
| Disease-Free Survival(DFS) | 2 years postoperative and 5 years postoperative. | The period from treatment initiation to any disease recurrence (local, regional, or distant) or death.If above event appears, record the time and disease location. |
| Breast Cancer-Specific Survival (BCSS) | 2 years postoperative and 5 years postoperative. | The time from the date of diagnosis to the date of death specifically attributed to breast cancer. Deaths from other causes are considered competing events and are censored. |
| Overall Survival(OS) | 2 years postoperative and 5 years postoperative. | The time from treatment initiation (or diagnosis) to death from any cause. If death appears, record the time and reason. |
Countries
China
Contacts
CONTACTZhenggui Du Du
Outcome results
None listed