Submental Flap for the Reconstruction of Hypopharyngectomy

Recruiting now · Not applicable

Conditions studied: Head and Neck Cancers - Hypopharyngeal

In brief

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.

Key facts

Study ID: NCT06161779
Run by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
People needed: 40
Starts: 2023-02-16
Expected to finish: 2030-02-16
Last updated by the study team: 2023-12-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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