Surgical versus Conservative Complex Physical Decongestion Therapy (CDT) for Chronic Breast Cancer-Related Lymphedema (BCRL): A Pragmatic, Randomized, Multicenter Superiority Trial
Research Project | 2 Project Members
Chronic lymphedema, whether primary or secondary, is a chronic and to date uncurable disease. Even though, primary lymphedema is rather rare, yet, we assume that secondary lymphedema is associated with a yearly incidence of up to 2% in industrialized countries, i.e. ~8‘000 new cases in Switzerland respectively ~80‘000 new cases in Germany.Accordingly, secondary lymphoedema of the upper extremities extremity affects a large number of patients treated for breast cancer. Depending on the cause of lymphoedemadefinition used, its incidence can vary from around ~20% (surgery-induced) up to over 50% (radio-therapy-induced) in Breast Cancer Patients.Cancer patients affected by arm lymphoedema of the arm suffer from swelling, feeling of heaviness or tightness, restricted range of motion, aching or discomfort, recurring infections and eventually hardening and thickening of the skin and subcutaneous tissue from pain, heaviness, and numbness with limited range of motion.
Swelling and structural changes of the extremity do not only lead to severe somatical impairments but have a significant psycho-social morbidity which can result in body dysmorphia and development of anxiety. Chronic lymphoedema is classified into 4 stages:Stage 0: Latent or preclinical stage of lymphoedema; Stage 1: Early accumulation of fluid that is relatively high in protein content and reversible with conservative treatment; Stage 2: Increase in swelling and morphological tissue changes not reversible to conservative treatment; Stage 3: Lymphostatic stage with hard, fibrotic tissues subject to infections (elephantiasis),To date, the gold-standard therapy of cronic lymphoedema is conservative complex physical decongestion therapy (CDT) that includes gentle massage, local compression, physical exercises and meticulous skin care.
Unfortunately, many patients affected with symptomatic lympoedema stages often depend on life-long conservative therapy that is only symptomatic. It is best performed on a regular base to be effective with the aim to maintain the condition of advanced lymphoedema stages rather than to improve it. Treatment of lymphoedema in these patients is often unsatisfactory with conservative therapy being ineffective and/or purely symptomatic, as well as very expensive over a life time (11). Originally, lymphedema surgery included only lymphoreductive procedures that aim at decreasing tissue excess resulting from severe lymphostatic stages, such as radical circumferential debulking of skin and subcutaneous tissue followed by defect coverage with or without skin graft or yield at linking dermal skin flaps with the underlying fascia and muscle to somehow connect the superficial lymphatic drainage system to the deep one. Unfortunately, these invasive procedures are associated with a rather high rate of pain, wound healing complication, infection and lymph fistulas and therefore nowadays are used only occasionally in countries of the first world in cases of severe elephantiasis.
More recently, suction-assisted lipectomy has been propagated to effectively remove hypertrophic fat (1997: Brorson) and fortunately is associated with far less surgery-associated morbidity, however requires life-long compression garments to be effective. With novelecent developments including improved knowledge of lymphatic anatomy and physiology, as well as availability of more powerful diagnostic devices and of (super-) microsurgical techniques,- two main therapeutic surgical options have emerged: vascularized Vascularized lymph node transfer (VLNT) and lymphaticovenous anastomosis (LVA). It has been demonstrated that VLNT is able lastingly to reduces chronic lymphoedema and improves quality of life, also in a more cost-effective way when compared to CDT alone, while LVA on the other hand results in improved objective and subjective patient outcomes, e.g.such as symptom relief in 50-100% of patients. Nowadays, LVA seems to be indicated in stage I and early stage II lymphoedema, whereas VLNT is rather performed in late stage II and stage III (associated with lympho-liposuction) lymphoedema.
Based on the current evidence available, we therefore do hypothesize that the novel (super-)microsurgical lympho-reconstructive techniques (VLNT and LVA) are superior to conservative treatment options alone. Our study goal is to demonstrate that these surgical techniques, that restore lymphatic drainage, including VLNT as well LVA, are superior (i.e. more efficient and cost-effective, resulting in higher quality of life of affected patients) compared to conservative methods in the treatment of chronic breast cancer related chronic lymphoedema.
