Status:
RECRUITING
Submental Flap for the Reconstruction of Hypopharyngectomy
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Head and Neck Cancers - Hypopharyngeal
Eligibility:
All Genders
18-80 years
Phase:
NA
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 resect...
Detailed Description
1. Introduction: Hypopharyngeal cancer is a common malignant tumor of the head and neck, ranking 27th in the world in 2020. Current treatments for hypopharyngeal carcinoma include surgical resecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 16 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06161779
Start Date
February 16 2023
End Date
February 16 2030
Last Update
December 8 2023
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120