LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorStanford University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Primary lymphedema of the affected upper limb
Secondary lymphedema of the affected limb prior to the lymphadenectomy
Radiotherapy at the axilla before the study / surgery
Allergic reaction to porcine collagen or ICG
Trial design
Design model
Parallel
Treatments tested in this trial
axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)
Procedure/Surgerylymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
Axillary lymphadenetomy alone
Procedure/Surgeryoncologic axillary lymphadenectomy
axillary lymphadenectomy with soft tissue reinforcement
Procedure/Surgeryaxillary lymphadenectomy with soft tissue reinforcement(STR)
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Group AOther 1 intervention
Group B: Group BActive comparator 1 intervention
Group C: Group CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Lymphatic flow pattern of whole limb
In the early lymphedema stages this exam allows to detect percutaneously the lymphatic vessels of the whole limb, up to about 1 cm in depth from the skin surface, by an infrared camera visualization system after intra-dermal injection of ICG in the hand. The change in the lymphatic pattern and reduction in the ICG velocity will be tested to find a correlation with other used diagnostic parameters like volume change and bioimpedance spectroscopy.
Time frame
2 yr2
Limb Volume
Limb volume as measured by serial assessment
Time frame
2 yr3
Skin thickness measurements
Skin thickness is changed by lymphedema
Time frame
2 yr4
Bioiimpedance spectroscopy
Impedance of the skin changes with lymphedema
Time frame
2 yrSponsors and contacts
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Source ClinicalTrials.gov