Use of New Microsurgical Techniques for Lymphedema Following Breast Cancer

Lymphedema following breast cancer (Breast Cancer-Related Lymphedema, BCRL) occurs when lymphatic vessels are damaged by surgery or radiation therapy as part of cancer treatment. This causes fluid to accumulate in the tissue, usually in the arm, which can lead to swelling, pain, limited mobility, and infections. This condition is typically treated with complex physical decongestive therapy (CDT). This includes manual lymphatic drainage, compression bandages or stockings, exercise therapy, and skin care. Although this therapy can alleviate symptoms, it is only symptomatic and often cannot prevent the progression of the disease. In specialized centers, microsurgical procedures have been developed that address the underlying cause. In lymphovenous anastomosis (LVA), very small lymphatic vessels are connected directly to veins, allowing excess fluid to drain. In vascularized lymph node transfer (VLNT), healthy lymph nodes are transplanted to form new lymphatic pathways. Both methods have shown promising results with few complications in previous studies; however, a large, international comparison with standard therapy is still lacking.

The aim of this study is to examine whether a specific microsurgical procedure improves quality of life more than the current standard therapy. There are two study arms into which patients are randomly assigned. In the surgical study arm, patients undergo microsurgical surgery designed to improve impaired lymphatic drainage and directly treat the causes of lymphedema. In the conservative treatment arm, patients receive standard therapy (complex physical decongestive therapy). The primary endpoint of the study is whether patients have a better quality of life after 15 months. The study is expected to run until 2036, with regular follow-up visits for up to ten years.

Eligible participants include women and men aged 18 and older with lymphedema resulting from breast cancer that has been present for at least three months, who have already received conservative therapy and are willing to undergo surgery. Excluded are individuals with congenital or non-breast-cancer-related lymphedema, those who have already undergone lymphedema surgery on the affected arm, or those for whom the treating surgeons do not see an indication for surgery.