Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06161779

Submental Flap for the Reconstruction of Hypopharyngectomy

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-12-08

40

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Submental Flap for the Reconstruction of Hypopharyngectomy

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • T2-T3 hypopharyngeal squamous cell carcinoma located in the piriform sinus or posterior hypopharyngeal wall cancer
  • The contralateral hemilarynx is mobile
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • No history of radiotherapy
Not Eligible

You will not qualify if you...

  • Invasion into the cricoid cartilage making larynx preservation impossible
  • Pulmonary insufficiency with FEV1/FVC less than 50%
  • Unresectable neck diseases including carotid artery involvement or tumor penetration to prevertebral fascia or mediastinum
  • Heart insufficiency that prevents tolerating general anesthesia
  • Presence of distant metastasis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

R

Renhui Chen, MD

CONTACT

L

Liushan Ou, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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