[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578777":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":71,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Vascularized lymphatic transplantation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"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.\n\nAdjusting 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.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Wang Youyuan, Doctor","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":28,"email":29},"CONTACT","13631333312","86","Wangyy78@mail.sysu.edu.cn",[31],{"facility":32,"status":19,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":19},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","Guangzhou","Guangdong","510120","China","CN",{"type":39,"coordinates":40},"Point",[41,42],113.25,23.11667,{"lat":42,"lon":41},{"type":23,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Youyuan Wang","Associate Chief Physician","100578777","reconstruction-of-cervical-lymphatic-system-during-head-and-neck-squamous-cell-carcinoma-surgery-100578777",false,"NCT06815705","Reconstruction of Cervical Lymphatic System During Head and Neck Squamous Cell Carcinoma Surgery","An Exploratory Study of Reconstruction of Cervical Lymphatic System by Vascularized Lymphoid Tissue Transplantation During Head and Neck Squamous Cell Carcinoma Surgery","Inclusion Criteria:\n\n1. 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.\n2. No history of other malignant tumors 3.18-75 years old\n\n4\\. Baseline check is normal:\n\n1. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) ≥1.5x109\u002FL;\n2. Platelets ≥100×109\u002FL in the past 14 days without blood transfusion;\n3. Hemoglobin \\>9g\u002FdL in the last 14 days without blood transfusion or use of erythropoietin;\n4. Total bilirubin ≤1.5× upper limit of normal (ULN);\n5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);\n6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft- Gault formula) ≥60 ml\u002Fmin;\n7. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n8. 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;\n9. 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);\n10. 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\n\n    1 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;\n11. 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).\n12. No axillary lymph node metastasis.\n\nExclusion Criteria:\n\n1. Diagnosis of other malignant tumors, or treatment of HNSCC did not start.\n2. 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;\n3. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n4. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n5. 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);\n\n   Note: Hepatitis B subjects who meet the following criteria can also be enrolled:\n   1. Pre-treatment HBV viral load \\\u003C1000 copies \u002Fml (200 IU\u002Fml), subjects should receive anti-HBV therapy throughout study treatment to avoid viral reactivation\n   2. 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\n6. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n7. Pregnant or lactating women;\n8. The presence of any serious or uncontrolled systemic disease, such as:\n\n   1. 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;\n   2. Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;\n   3. 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;\n   4. Poor blood pressure control (systolic \\> 140 mmHg, diastolic \\> 90 mmHg);\n   5. There is a history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to treatment, or there is currently clinically active interstitial lung disease;\n   6. Active pulmonary tuberculosis;\n   7. There is an active or uncontrolled infection that requires systemic treatment;\n   8. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;\n   9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n   10. Poor diabetes control (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n   11. Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity \\> 1.0 g;\n   12. Patients with mental disorders who cannot cooperate with treatment;\n9. Axillary lymphatic metastasis\n10. Medical history or evidence of disease that may interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers other potential risks unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":58,"type":59},23,"ESTIMATED","INTERVENTIONAL",[62],"NA","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.\n\nVascularized 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.\n\nAt 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.\n\nTherefore, 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.",[65,66,67,68],"Head and Neck Squamous Cell Carcinoma","Lymphedema, Secondary","Neck Lymph Dissection","Vascularized Lymph Node Transplantation",[70,65],"Vascularized lymph node transplantation","NOT_YET_RECRUITING","2025-02-03",{"date":74,"type":75},"2025-02-07","ACTUAL",{"date":77,"type":59},"2025-03-20",{"date":79,"type":59},"2027-12",{"name":5,"class":6},1]