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Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.
Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LYMPHA | Experimental | LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches. |
|
| Control | Active Comparator | No LYMPHA procedure is performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYMPHA | Procedure | Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of lymphedema | To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery. | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| UEL index | To compare the UEL index | 2 years after surgery |
| Changes in Lymphoscintigraphy | To compare the changes in lymphoscintigraphy presented by the change of transport index (TI) |
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Inclusion Criteria:
Exclusion Criteria:
Female patient
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soong June Bae, M.D. | Contact | 82-2-2019-4401 | mission815815@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital, Yonsei University College of Medicine | Recruiting | Seoul | 06273 | South Korea |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| control | Procedure | In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up. |
|
| 2 years after surgery |
| Incidence of lymphedema | To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery. | 5 years after surgery |
| 5-year recurrence rate | To compare the recurrence rate | 5 years after surgery |
| 5-year overall survival rate | To compare the overall survival rate | 5 years after surgery |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |