None listed
Conditions
Brief summary
This study will investigate a new technique, immediate lymphaticovenous anastomosis (ILA), to preserve lymphatic drainage and prevent the development of breast cancer–related lymphedema. Who is it for? You may be eligible for this study if you are a female diagnosed with breast cancer and require axillary lymph node dissection (ALND). Study details During ALND, a fluorescent dye will be used to map the lymphatic vessels, which will then be joined to adjacent veins under high magnification using supermicrosurgical techniques. Follow-up data on the incidence of post-operative breast cancer–related lymphedema and any other surgical complications will be collected up to 12 months post-operatively. It is hoped that findings from this study will help identify new methods to manage the incidence of breast cancer–related lymphedema in those undergoing axillary lymph node dissection.
Interventions
The intervention involves performing immediate lymphaticovenous anastomosis (ILA) at the time of axillary lymph node dissection (ALND) for breast cancer. Indocyanine green (ICG) fluorescence axillary reverse mapping (ARM) is used intraoperatively to identify lymphatic vessels draining the upper limb. ICG (2.5 mg/mL) is injected intradermally into the upper inner arm, and a near-infrared fluorescence imaging system is used to visualize the lymphatic channels. Identified lymphatic vessels are preserved and anastomosed to adjacent veins using supermicrosurgical techniques under high magnification. The procedure is performed by a trained plastic and reconstructive surgeon. The intervention is typically completed within 45 to 60 minutes. Adherence to the intervention is monitored and documented in the operative report, including details of lymphatic identification and the number of anastomoses performed. No additional lymphedema-specific therapies are administered postoperatively.
Sponsors
Study design
Eligibility
Inclusion criteria
• Female patients aged 18 years or older • Diagnosis of breast cancer requiring axillary lymph node dissection (ALND) • Willing and able to provide informed consent • Planned surgery to be performed at the participating institution
Exclusion criteria
• Pre-existing ipsilateral lymphedema • Known allergy or hypersensitivity to indocyanine green (ICG) • Iodine allergy • Chronic kidney disease stage 3, 4, or 5 • Pregnancy