RecruitingNot ApplicableNCT04687956

Primary Surgical Prevention of Breast Cancer-related Lymphedema

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


Sponsor

Gangnam Severance Hospital

Enrollment

72 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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

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.


Locations(1)

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

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NCT04687956


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