Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

NCT06024980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-13

No results posted yet for this study

Summary

Recruited patients are divided into two arms depending on laryngeal carcinoma's T1 and T2 stages. Two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (OPHL). During the pre-and post-operative time, patients performed measurements of swallowing function, including direct subglottic pressure, Eating Assessment Tool-10(EAT-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(FEES). Patients undergo subglottic pressure measurement and swallowing function evaluation three times: 3-7 days, two months, and six months after surgery. Patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation.

Conditions

Interventions

PROCEDURE

Open partial horizontal laryngectomy(OPHL), Type I-III

An open partial horizontal laryngectomy(OPHL) was performed for patients with T2 supraglottic and glottic carcinoma, according to the American Joint Committee on Cancer(AJCC) criteria. Type I OPHL: Entails the resection of the supraglottis, including the pre-epiglottic space and the upper half of the thyroid cartilage. Type II OPHL: Entails the resection of the entire thyroid cartilage, with the inferior limit represented by the upper edge of the cricoid ring. Type III OPHL: Entails the resection of the entire supraglottic, glottic, and part of the subglottic sites, sparing both or at least one functioning crico-arytenoid unit.

PROCEDURE

Transoral endoscopic laser cordectomy

For patients with T1 glottic laryngeal carcinoma, according to the criteria of the American Joint Committee on Cancer(AJCC), transoral endoscopic CO2 laser(2-40Watts) cordectomy was performed. The classification comprises eight types of cordectomies: * A subepithelial cordectomy (type I) is a resection of the epithelium of the vocal fold. * A subligamental cordectomy (type II) is a resection of the epithelium, Reinke's space, and vocal ligament. * Transmuscular cordectomy (type III), which proceeds through the vocalis muscle. * Total cordectomy (type IV). * Extended cordectomy encompasses the contralateral vocal fold and the anterior commissure (type Va). * Extended cordectomy, which includes the arytenoid (type Vb). * Extended cordectomy, which encompasses the subglottis (type Vc). * Extended cordectomy, which consists of the ventricle (type Vd).

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Xujiao Chen, Ms · Guangdong Provicial People's Hospital(Guangdong Academy of Sciences), Southern Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2025-11-01
Completion
2025-12-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06024980 on ClinicalTrials.gov