Breast Cancer, Lymphedema, Mastectomy
Conditions
Brief summary
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
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.
Interventions
PROCEDURELYMPHA
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.
PROCEDUREcontrol
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 19 years old 2. 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
1. Patients with vascular and lymph-related diseases 2. Patients with a history of surgical treatment or trauma to both arms and axillary 3. Patients with a history of receiving radiation treatment in both arms, chest, and axilla 4. Patients with confirmed systemic metastasis with stage 4 breast cancer 5. Pregnant and lactating patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of lymphedema | 2 years after surgery | To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 2 years after the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UEL index | 2 years after surgery | To compare the UEL index |
| Changes in Lymphoscintigraphy | 2 years after surgery | To compare the changes in lymphoscintigraphy presented by the change of transport index (TI) |
| Incidence of lymphedema | 5 years after surgery | To compare the incidence of lymphedema assessed by UEL index and lymphoscintigraphy at 5 years after the surgery. |
| 5-year recurrence rate | 5 years after surgery | To compare the recurrence rate |
| 5-year overall survival rate | 5 years after surgery | To compare the overall survival rate |
Countries
South Korea
Contacts
Primary ContactSoong June Bae, M.D.
Outcome results
None listed