Reconstruction of Cervical Lymphatic System During Head and Neck Squamous Cell Carcinoma Surgery

NCT06815705 | Not Yet Recruiting

• 1 other identifier: SYSJS-2024-074-02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Lymphedema, Secondary; Neck Lymph Dissection; Vascularized Lymph Node Transplantation

Keywords

Vascularized lymph node transplantation; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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.

  At least 3 months to 2 years after surgery

• 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.

  At least 3 months to 2 years after surgery

Secondary Outcomes (6)

• The survival of transplanted lymph nodes at 3 months and 6 months after comprehensive treatment

  3，6，12，24 months after comprehensive treatment

• Incidence of upper limb lymphedema in donor area

  At least 6 months to 2 years after surgery

• degree of upper limb lymphedema in donor area

  At least 6 months to 2 years after surgery

• 2-year disease-free survival

  within 2 years after surgery

• 2-year overall survival

  within 2 years after surgery

Study Arms (1)

Vascularized lymphatic transplantation

EXPERIMENTAL

Surgical methods According to the guidelines, the tumor was removed, the neck lymph node was removed, and the maxillofacial and neck defects were repaired with vascularized thoracic artery flap and axillary lymphatic tissue transplantation.

Procedure: Vascularized lymphatic transplantation

Interventions

Vascularized lymphatic transplantation PROCEDURE

Preoperative 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.

Vascularized lymphatic transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. Baseline check is normal:
• 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;
• Hemoglobin \>9g/dL in the last 14 days without blood transfusion or use of erythropoietin;
• Total bilirubin ≤1.5× upper limit of normal (ULN);
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);
• Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft- Gault formula) ≥60 ml/min;
• Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
• Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
• The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included);
• For female subjects of reproductive age, a urine or serum pregnancy test should be taken and the result is negative within 3 days prior to the first treatment (day
• of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;
• If there is a risk of conception, all subjects (male or female) should use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last treatment (or 180 days after the last chemotherapy drug administration).

You may not qualify if:

• 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);
• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center);
• Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• Pre-treatment HBV viral load \<1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy throughout study treatment to avoid viral reactivation
• For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required
• Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
• Pregnant or lactating women;
• The presence of any serious or uncontrolled systemic disease, such as:
• The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;
• Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;
• Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;
• Poor blood pressure control (systolic \> 140 mmHg, diastolic \> 90 mmHg);

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (13)

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MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Lymphedema; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wang Youyuan, Doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Youyuan, Doctor

CONTACT

13631333312; Wangyy78@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: February 7, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after the primary study results are published, within 5 years after the study is published
• Access Criteria: 1. Access is typically granted only to researchers with legitimate scientific or public health research aims. Researchers must usually provide evidence that their proposed study has been approved by an Institutional Review Board or Ethics Committee. 2. The precise research purpose for which the IPD can be used, and not for unrelated or commercial purposes. Researchers required to properly acknowledge the original study team in any publications or presentations based on the data. 3. Access is granted with the expectation that the researcher will ensure participant privacy is maintained. Researchers must comply with relevant data protection laws. 4. IPD may only be used for specific types of secondary research, such as exploratory analyses, meta-analyses, or validation studies. No Commercial Exploitation. 5. We may require periodic reporting or auditing to ensure that the data is being use.

Locations

CN (1)