Primary Surgical Prevention of Breast Cancer-related Lymphedema

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema

Conditions
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Lymphedema, Mastectomy, Breast Cancer

Intervention / Treatment
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* Procedure: LYMPHA
* Procedure: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 19 years old Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery. Exclusion Criteria: Patients with vascular and lymph-related diseases Patients with a history of surgical treatment or trauma to both arms and axillary Patients with a history of receiving radiation treatment in both arms, chest, and axilla Patients with confirmed systemic metastasis with stage 4 breast cancer Pregnant and lactating patients

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LYMPHA<br>LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches. | Procedure: LYMPHA<br>* 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.<br>|
| Active Comparator: Control<br>No LYMPHA procedure is performed | Procedure: control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |