Primary Surgical Prevention of Breast Cancer-related Lymphedema
NCT ID: NCT04687956
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2021-02-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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LYMPHA
LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
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.
Control
No LYMPHA procedure is performed
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Gangnam Severance Hospital
OTHER
Responsible Party
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Joon Jeong
Professor
Locations
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Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3-2020-0343
Identifier Type: -
Identifier Source: org_study_id
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