A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Stanford University
Summary
Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life
Eligibility
- Age range
- 18–75 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Ages 18 to 75 years (inclusive) * Patients undergoing unilateral or bilateral breast cancer related axillary lymphadenectomy * Free of distant metastasis in preoperative screening * Histology results of axillary lymph nodes could be either Negative or Positive * Patients who undergo preoperative chemotherapy can be included * Willingness and ability to provide written informed consent * Willingness and ability to comply with all study procedures Exclusion Criteria: * Primary lymphedema of the affected upper limb * Secondary lymphedema of the affected limb prior to the…
Interventions
- Procedureaxillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)
lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
- ProcedureAxillary lymphadenetomy alone
oncologic axillary lymphadenectomy
- Procedureaxillary lymphadenectomy with soft tissue reinforcement
axillary lymphadenectomy with soft tissue reinforcement(STR)
Location
- Stanford Cancer InstituteSan Francisco, California