Reconstruction of Cervical Lymphatic System During Head and Neck Squamous Cell Carcinoma Surgery
NCT06815705 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2025-02-07
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
Interventions
- PROCEDURE
-
Vascularized lymphatic transplantation
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.
Sponsors & Collaborators
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
lead OTHER
Principal Investigators
-
Wang Youyuan, Doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-20
- Primary Completion
- 2027-01-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
More Related Trials
-
Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma
NCT04678791 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Identification of Pattern and Factors Affecting Recurrence in Head and Neck Carcinoma
NCT06465030 ·Status: RECRUITING
-
Combination of Cryosurgey and NK Immunotherapy for Recurrent Cervical Cancer
NCT02849340 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma
NCT06576180 ·Status: RECRUITING
-
Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer
NCT00544414 ·Status: COMPLETED ·Phase: PHASE2
-
Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer
NCT02079324 ·Status: COMPLETED ·Phase: PHASE1
-
Organ Preservation in the Multispeciality Therapy of Stage II-IV Locally Advanced Head and Neck Cancer
NCT01187472 ·Status: COMPLETED
-
Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT00805012 ·Status: TERMINATED ·Phase: PHASE2
-
Anti-tumor Specific Immune Response in Head and Neck Cancers
NCT02881918 ·Status: UNKNOWN
-
Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer
NCT05378087 ·Status: RECRUITING ·Phase: NA
-
Phase II Multi-centered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT06814067 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Virtual Reality 3D-Surgery Modeling to Enhance Head and Neck Cancer Surgery Quality
NCT05031910 ·Status: RECRUITING ·Phase: NA
-
Recipient Vessels for Free Tissue Flaps in Advanced Oncologic Defects of the Midface and Scalp
NCT05749120 ·Status: COMPLETED ·Phase: NA
-
Advanced First-line Treatment of Short-term Postoperative Progression of Head and Neck Squamous Cell Carcinoma
NCT06170697 ·Status: UNKNOWN ·Phase: PHASE2
-
Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
NCT03010150 ·Status: RECRUITING
-
Definitive Chemo-Radiotherapy for Regionally Advanced Head and Neck Cancer With or Without Up-front Neck Dissection
NCT02918955 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
NCT07125755 ·Status: RECRUITING ·Phase: PHASE3
-
Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer
NCT06775756 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck
NCT02776137 ·Status: COMPLETED ·Phase: PHASE2
-
Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer
NCT01487226 ·Status: UNKNOWN ·Phase: PHASE2
-
2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
NCT06492460 ·Status: RECRUITING ·Phase: PHASE3
-
Change in Symptom Clusters in HNC Patients
NCT03356093 ·Status: COMPLETED
-
A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma
NCT05668858 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer
NCT01111942 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
NCT02595554 ·Status: UNKNOWN ·Phase: PHASE3