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A growing number of Chinese breast cancer patients are diagnosed at a young age. The quality of life of young breast cancer patients has been a critical issue. Breast-conserving surgery (BCS) not only removes the tumor but also maintains the appearance of breast. The Breast Tumor Center of Sun Yat-sen Memorial Hospital is one of the first departments in China to perform breast-conserving surgeries. Endoscopic breast surgery has emerged as a promising surgical approach. However, it is hard to delineate the tumor margins in endoscopic BCS, which restrains its development. In traditional BCS, surgeons determine the tumor border by palpation, which is impossible in endoscopic BCS. For the first time, we performed the intra-operative navigation system-assisted endoscopic breast-conserving surgery, in which the tumor border was accurately delineated using the navigation system.
In the study, patients who are female aged between 18 and 70 years, are pathologically diagnosed operable breast cancer, have proper the important organ functions and adjust to the criteria of endoscopic breast conserving surgery. Intraoperative and post-operatitive Margin Assessment will be the primary outcome measure, and aesthetic outcomes, reoperation rate, as well as patients' feedback will be the secondary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Breast Conserving Surgery With Intra-operative Navigation System | Experimental | Surgerons will use Intra-operative navigation system during the surgery to delineate the margins of tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-operative Navigation System | Device | In the experimental group,a navigation technology was used to identify tumor margins during the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Final Margin Assessment | Pathological results of the margins. Negative margins are defined as "no ink on tumor". Positive marginsare defined according to the Society of Surgical Oncology consensus guidelines as ink on tumor for invasive cancer with or without DCIS component or cancer cells present within 2mm from the inked surface for pure DCIS. | two weeks to one month |
| Measure | Description | Time Frame |
|---|---|---|
| ABNSW system (Aesthetic Outcome) | ABNSW system. The total score was 15 points, outcomes were good when it was 11-14, fair when it was 6-10, and poor when it was 0-5. | half a year to one year |
| Reoperation Rate |
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Inclusion Criteria:
WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.5×10^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shicheng Su, M.D., Ph.D. | Contact | +86 13631304227 | sushch@mail.sysu.edu.cn |
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| 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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| ID | Term |
|---|---|
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
the rate that margins needs to be reoperated due to incomplete excision
| one month |
| Patients' Feedback | Breast Q assessment. The assessment includes seven questionnaires that shows patients'feedback post-operatively. | half a year to one year |