LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

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 lymphadenectomy
• Radiotherapy at the axilla before the study / surgery
• Allergic reaction to porcine collagen or ICG
• Receiving radiation therapy to the involved nodal basin in a period less than 4 weeks after the surgery
• Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening
• Other medical condition that could lead to limb edema, such as (but not limited to primary lymphedema or acute venous thrombosis
• Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (e.g., pain, swelling, decreased range of motion)
• Either of the following, at the time of baseline evaluation: ipsilateral:contralateral limb volume ratio>1.1 or R0 bioimpedance ratio > 1.106 when the nondominant limb is at risk, and 1.134 when the dominant limb is at risk.
• Life expectancy < 2 years for any reason
• Pregnancy or nursing
• Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
• Severe psychiatric disease
• Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires dialytic support
• Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 × ULN at screening
• Absolute neutrophil count < 1500 mm3 at screening
• Hemoglobin concentration < 9 g/dL at screening
• Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study