Primary Surgical Prevention of Breast Cancer-related Lymphedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LYMPHA, control.
- Who it may be relevant to
- Registry conditions: Lymphedema, Mastectomy, Breast Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema
Overview
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
- Procedure LYMPHA
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. - Procedure control
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.
Primary outcome measures
- Incidence of lymphedema [Time frame: 2 years after surgery]
Secondary outcome measures (5)
- UEL index [Time frame: 2 years after surgery]
- Changes in Lymphoscintigraphy [Time frame: 2 years after surgery]
- Incidence of lymphedema [Time frame: 5 years after surgery]
- 5-year recurrence rate [Time frame: 5 years after surgery]
- 5-year overall survival rate [Time frame: 5 years after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Gangnam Severance Hospital, Yonsei University College of Medicine — Seoul
Identifiers
NCT: NCT04687956 · 3-2020-0343