Lymphedema, Secondary

The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score. A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.

Head and neck squamous cell carcinoma is one of the most common malignant tumors. At present, the standard treatment of head and neck squamous cell carcinoma recommended by the National Comprehensive Cancer Network(NCCN) treatment guideline in the United States and the Chinese Society of Clinical Oncology(CSCO) treatment guideline in China is a comprehensive treatment model based on surgery, supplemented by radiotherapy, chemotherapy, immunization and targeted therapy. Neck lymph dissection is one of the most important surgical procedures for the treatment of head and neck squamous cell carcinoma. The injury of surgery and postoperative adjuvant radiotherapy leads to inadequate drainage of lymphatic system, leading to head and neck lymphedema. Vascularized lymph node transplantation is successfully used in the treatment of upper and lower limb lymphedema, but has not been reported in the treatment of head and neck lymphedema. At present, neck lymph dissection is the standard surgical protocol for head and neck squamous cell carcinoma, and there is no clear evidence that neck lymph dissection can be avoided. The dorsal thoracic artery flap can be used to make the flap of chimeric axillary lymph node, and can also be used as one of the vascularized lymph transplantation donor areas for the treatment of lymphedema without increasing the risk of upper limb lymphedema in the donor area. Therefore, the investigators propose: Can the function of the head and neck lymphatic system be reconstructed by transplanting normal lymph nodes from other parts of the body into the neck to form new lymphatic pathways at the same time of operation for head and neck squamous cell carcinoma? In our previous operation for head and neck squamous cell carcinoma, thoracic dorsal artery flap with partial axillary lymphoid tissue transplantation was used to repair head and neck defects. Retrospective analysis showed that the lymph node transplantation in the previous cases survived. Therefore, this project designed a prospective exploratory clinical study to clarify the activity and donor safety of cervical vascularized lymphatic transplantation, and further explore the effect of vascularized lymphatic tissue transplantation to rebuild the cervical lymphatic system in reducing the incidence of postoperative head and neck lymphedema, alleviating cervical fibrosis after radiotherapy and even improving the prognosis of patients.

This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.