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In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.
Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. The operator can track the lymphatic pathway without skin incision in real time. By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. This is why we can identify the lymphatic metastasis pathway of breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective Lymph Node Dissection | Experimental | 10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery. Routine axillary lymph node dissection is performed. Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axillary lymph node dissection | Procedure | Lymph node dissection is performed in axillary lymph node level I and II. In case of palpable nodes in level II, additional lymph node dissection in level III is done. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist | Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes. | within 2 weeks (plus or minus 3 days) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes | Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis | within 2 weeks (plus or minus 3 days) after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SeokWon Kim, MD. PhD. | Contact | +82-2-3410-3479 | seokwon1.kim@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| SeokWon Kim, MD. PhD. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Indocyanine green | Drug | 10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery |
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| Imaging devices | Device | Near-infrared fluorescence is collected by imaging lenses and digital camera. |
|
| D017437 |
| Skin and Connective Tissue Diseases |