NCT06161779 Submental Flap for the Reconstruction of Hypopharyngectomy
| NCT ID | NCT06161779 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Head and Neck Cancers - Hypopharyngeal |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-02-16 |
| Primary Completion | 2028-02-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-02-16 with a primary completion date of 2028-02-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to assess the safety and efficacy of submental artery island flap (SMAIF) in the reconstruction of laryngeal and hypopharyngal defects after the surgical resection of hypopharyngeal cancer. The main questions it aims to answer are: * The survival of SMAIF and the recovery of laryngeal function. * The oncologic outcomes of SMAIF comparing with other reconstructions or radiotherapy. Participants will underwent partial laryngectomy and hypopharyngectomy and reconstruction of SMAIF. Postoperative adjuvant radiotherapy will be recommented when adverse pathologic features were noted.
Eligibility 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.
Contact & Investigator
Xiaoming Huang, MD
PRINCIPAL INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT06161779 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Head and Neck Cancers - Hypopharyngeal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06161779 currently recruiting?
Yes, NCT06161779 is actively recruiting participants. Contact the research team at chenrh23@mail.sysu.edu.cn for enrollment information.
Where is the NCT06161779 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06161779 clinical trial?
NCT06161779 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Xiaoming Huang, MD at Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 40 participants.
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