Reconstruction of throat defects after cancer surgery using a specific flap technique
Official title: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06161779 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | February 16, 2023 |
| Main results expected | February 16, 2028 |
| Study ends | February 16, 2030 |
| Registry record updated | December 8, 2023 |
| Trial ID | NCT06161779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.