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With the title of "Long-Term Outcomes of endoscopic-assisted vs conventional breast-conserving surgery in breast cancer patients after neoadjuvant therapy: a randomized, multicenter, open label, non-inferiority trial", this study targets breast cancer patients after neoadjuvant therapy. A total of 1380 eligible patients, after screening with inclusion and exclusion criteria, will be randomly assigned to Endoscopic-assisted breast conserving surgery(E-BCS) or conventional breast conserving surgery (C-BCS) group at a 1:1 ratio using stratified block randomization method, stratified by centers and molecular subtype. The co-primary endpoints are 5-year disease-free survival (5y-DFS) and Breast-Q score at 6 months after surgery. The secondary endpoints are cosmetic outcomes including surgeons' satisfaction with breast and patients' satisfaction with scar, survival outcomes including 5-year overall survival (5y-OS) and 5-year local-recurrence rate (5y-LRR), surgical outcomes including operative time, intraoperative blood loss, incision length and postoperative complications rate. This study aims to confirm the long-term safety and aesthetic outcome of endoscopic-assisted surgery in breast cancer patients after neoadjuvant treatment by comparing it with conventional open breast conserving surgery, and provide clinical evidence for the popularized application of endoscopic breast surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic breast-conserving surgery (E-BCS) group | Experimental |
| |
| Conventional breast-conserving surgery (C-BCS) group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | comparison of 2 surgical procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-year disease free survival | The proportion of patients remaining after excluding patients with disease recurrence, metastasis or death from the time of surgery to 5-year follow-up | From surgery to the end of follow-up at 5 years |
| Patients' satisfaction with breast | The score of Breast-Q scale "Satisfaction with breasts" table 6 months after surgery | From surgery to the follow-up at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeons' satisfaction with breast | Surgeons evaluate the cosmetic outcome of breast based on the photos before surgery and after surgery. Four ranks: Excellent (9-10 points), Good (7-8 points), Fair (5-6 points) and Poor (0-4 points) are categorized on a basis of average total score from Ueda scale | From surgery to the follow-up at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shicheng Su | Contact | +86-13631304227 | sushch@mail.sysu.edu.cn | |
| Yiwen Lu, Doctor | Contact | +86-13268121885 | luyw8@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shicheng Su, Doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Patients satisfaction with scar | Scar-Q scale including 3 tables about the surgical scar: appearance, symptom, psychosocial impact with total score of 100 will be used for evaluating patients satisfaction with scar | From surgery to the follow-up at 6 months |
| 5-year overall survival | The proportion of patients remaining after excluding patients who died from any cause at 5-year follow-up | From surgery to the end of follow-up at 5 years |
| 5-year local-regional recurrence rate | The proportion of patients with a lump found on breast, axilla, chest wall, skin or scars of surgery ipsilateral to the surgical side through physical examination or imaging, confirmed as the same pathological type as the primary tumor according to biopsy at 5-year follow up | From surgery to the end of follow-up at 5 years |
| Postoperative complication rate | The proportion of patients with postoperative complications including hemorrhage, incision dehiscence, upper limb lymphedema, infection,seroma. | From surgery to the follow-up at 12 months |
| Surgical duration | The time from the beginning of surgery to the end of surgery | Intraoperative |
| Intraoperative blood loss | The blood loss during the operation | Intraoperative |
| Incision length | The length of surgical incision | Intraoperative |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shenzhen Shantou Central Hospital | Not yet recruiting | Shantou | Guangdong | China |
|
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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