Sponsor study identifier
interventional
72
1 country
1
Study Start
February 1, 2021
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2020
Actual (reported)December 29, 2020
Actual (reported)February 1, 2021
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
UEL index
2 years after surgery
Changes in Lymphoscintigraphy
2 years after surgery
Incidence of lymphedema
5 years after surgery
5-year recurrence rate
5 years after surgery
5-year overall survival rate
5 years after surgery
LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.
No LYMPHA procedure is performed
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.
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.
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, 06273, South Korea
First Submitted
November 29, 2020
First Posted
December 29, 2020
Study Start
February 1, 2021
Actual (reported)Primary Completion
December 31, 2027
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 11, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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