RecruitingNot ApplicableNCT06161779

Submental Flap for the Reconstruction of Hypopharyngectomy

Sun Yat-sen Memorial Hospital, Sun Yat-sen University


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

40 participants

Start Date

Feb 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

Interventions

OTHERSurgical reconstruction

submental artery island flap (SMAIF) for the reconstruction of laryngeal and hypopharyngal defects after the surgical resection of hypopharyngeal cancer


Locations(1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06161779