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Submental Flap for the Reconstruction of Hypopharyngectomy

RecruitingNAAges 18 Years - 80 YearsAllSun Yat-Sen Memorial Hospital of Sun Yat-Sen Univโ€ฆ
NCT06161779 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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๏ผ› * 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.
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What it tests

  • Surgical reconstruction
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Where

1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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