Reconstruction of throat defects after cancer surgery using a specific flap technique
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
This study is testing a new way to rebuild the throat after cancer surgery to see if it works well and helps people recover better than other methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06161779 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of the submental artery island flap (SMAIF) for reconstructing laryngeal and hypopharyngeal defects following surgical removal of hypopharyngeal cancer. Participants will undergo partial laryngectomy and hypopharyngectomy, with SMAIF used for reconstruction. The study aims to assess the survival of the flap, recovery of laryngeal function, and compare oncological outcomes with other reconstruction methods or radiotherapy. Postoperative adjuvant radiotherapy will be recommended if adverse pathologic features are present.
Who should consider this trial
Good fit: Ideal candidates include individuals with T2-T3 hypopharyngeal squamous cell carcinoma who have a mobile contralateral hemilarynx and an ECOG performance status score of 0 or 1.
Not a fit: Patients with invasion into the cricoid cartilage, pulmonary insufficiency, unresectable neck diseases, heart insufficiency, or distant metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the quality of life and functional outcomes for patients undergoing surgery for hypopharyngeal cancer.
How similar studies have performed: While the use of SMAIF for reconstruction is established, this specific approach in the context of hypopharyngeal cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * T2-T3 hypopharyngeal squamous cell carcinoma located in the piriform sinus or posterior hypopharyngeal wall cancer; * The contralateral hemilarynx is mobile; * the Eastern Cooperative Oncology Group (ECOG) performance status (PS) score was 0 or 1; * Without a history of radiotherapy. Exclusion Criteria: * Invasion into the cricoid cartilage and unable to reserve the larynx； * Pulmonary insufficiency, FEV1/FVC\<50%; * Unresctable neck diseases including carotid artery envoloped or tumor penetration to the prevertebral fascia or mediastinum; * Heart insufficincy whice intolerate to general anesthesia; * With distant metastasis.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Xiaoming Huang, MD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Renhui Chen, MD
- Email: chenrh23@mail.sysu.edu.cn
- Phone: +862081332587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.