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 selected T2-3,N0-3,M0; Patients with T4a,N0-3,M0 head and neck squamous cell carcinoma (AJCC 8th) can be treated surgically with flap repair and no axillary lymphatic metastasis.
No history of other malignant tumors 3.18-75 years old
In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109/L;
Platelets ≥100×109/L in the past 14 days without blood transfusion;
Diagnosis of other malignant tumors, or treatment of HNSCC did not start.
Prior to treatment, an active autoimmune disease requiring systemic treatment (e.g. use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within the previous 2 years. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
Single group
Vascularized lymphatic transplantation
Procedure/SurgeryPreoperative ultrasonography was performed to check the distribution, quantity and size of axillary lymph nodes. During the operation, methylene blue was injected subcutaneously into the elbow fossa to make the axillary lymph nodes in area B and D chromogenic, and avoid damage to the arm drainage lymph nodes. Adjusting the flap design according to the size of the defect. The perforating branches of lymphoid tissue in areas A and C of grade I were located about 3-5cm above the perforating branches of the skin, and moved towards the thoracic side to the lymphatic adipose tissue. Finally, the pedicle of the thoracic dorsal artery was separated, and the blood transport of the flap and the lymphatic adipose tissue was examined by fluorescence imaging and other methods. The lymphoid adipose tissue was placed in the neck area I and II, and fixed by suture. The arteriovenous microvessels in the thoracic dorsal were anastomosed to the vessels in the receiving area of neck.
Incidence of head and neck lymphedema within 2 years after surgery
Head and neck lymphedema refers to external and internal head and neck lymphedema caused by disruption of lymphatic pathways due to surgical neck lymph node dissection or radiotherapy. This disruption prevents lymphatic fluid from flowing from the soft tissue interstitium of the head and neck to the right lymphatic vessel and the left thoracic duct. The incidence rate of head and neck lymphedema within 2 years refers to the proportion of patients with head and neck lymphedema from at least 3 months to 2 years after surgery in all patients who underwent vascularized lymphatic transplantation. The degree of head and neck lymphedema is divided into 5 grades according to the MD Anderson Cancer Center(MDACC) Head and neck lymphedema(HNL) rating scale.
severity of head and neck lymphedema within 2 years after surgery
The degree of lymphedema was determined by comparing MRI images before and after treatment, and the thickness of the most severely affected area increased by no more than 50% compared with the original thickness, which was mild lymphedema. When the thickness increases between 50% and 100%, it is moderate lymphedema. When the thickness increases by more than 100%, it is severe lymphedema.
The survival of transplanted lymph nodes at 3 months and 6 months after comprehensive treatment
The number, morphology and hemodynamics of transplanted lymph nodes at 3, 6, 12 and 24 months after treatment were measured by color Doppler ultrasound, magnetic resonance imaging and radionuclide lymphography. Ultrasound showed that the blood flow signal of the surviving transplanted lymph nodes was lymphatic portal type.
Incidence of upper limb lymphedema in donor area
The proportion of patients with upper limb lymphedema at the donor site from at least 6 months to 2 years after surgery in all patients who were repaired with vascularized lymphedema free thoracic dorsal artery flap. The diagnosis of upper limb lymphedema was referred to a prospective clinical study conducted by the Mayo Clinic in the United States, in which bilateral upper limb circumference was measured every 5cm from the wrist transverse line to the axillary line. The edema volume used was defined as a postoperative interlimb difference of ≥10% from baseline. The formula was used to calculate the volume change: \[(\[VIp-VIb\] / Vib) 100\]-\[(\[Vcp-Vcb\] / Vcb) 100%\], where Vip is the volume of the postoperative arm on the same side; Vib is the baseline volume of the ipsilateral arm; Vcp is the volume of the contralateral arm after surgery; The Vcb is the baseline volume of the opposite arm at baseline.
degree of upper limb lymphedema in donor area
The degree of edema was evaluated using the World Health Organization lymphedema staging method, upper limb arm circumference measurement, shoulder joint range of motion, and ultrasonic measurement of skin and subcutaneous tissue thickness.
2-year disease-free survival
Proportion of patients who did not have disease recurrence or death within 2 years after receiving standard surgery in this program.
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