Role of Ultrasound in Laryngeal Lesions

February 23, 2018 updated by: Mennat-Alllah Samy Abdelaziz, Assiut University

Role of Ultrasound in Diagnosis of Laryngeal Lesions

The aim of the study is to assess the efficiency and limitations of ultrasound in detecting and characterizing laryngeal anatomy and study of some laryngeal disorders and their ultrasonographic appearance.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The larynx contains the vocal cords and serves as the opening to the tracheobronchial tree. Laryngeal lesions include: benign laryngeal tumors, contact ulcers, laryngitis, laryngeoceles, malignant laryngeal tumors, spasmodic dysphonia, vocal cord paralysis, vocal cord polyps, nodules and granulomas.

Laryngeal cancers account for about one quarter of all head and neck cancers, most of which affect the true vocal cords. Black men are affected more commonly than white men. The male to female incidence ratio is about 4:1.

Laryngeal cancer is the 19th most common cause of cancer death worldwide, with around 83,400 deaths from laryngeal cancer in 2012 (1% of total cancer deaths). Cancer of larynx is one of the most common malignancies in Europe, with about 52,000 new cases per year. The yearly incidence rate in Europe is about 8 per 100,000.

Different methods were used successfully for the diagnosis of many laryngeal diseases. Rigid endoscope was used for laryngeal evaluation with the advantage that the image is large, bright and clear which allows early diagnosis of the lesion (Shao et al, 2002).

Unfortunately, not all patients can tolerate the laryngoscope especially those with a sensitive gag reflex, patients with limit of jaw or neck mobility or patients suffering from stridor. It is also difficult in most infants and children .

Even during laryngoscopy the exact extension of laryngeal tumor, its infiltration and invasion of the laryngeal skeleton can sometimes be hard to assess. Thus, laryngoscopy alone may not be sufficient in some cases to judge the extent of infiltrative processes or measure the exact infiltration of a tumor. For this reason computed tomography (C.T) as well as magnetic resonance imaging (MRI) is often used to supplement laryngoscope as an additional imaging tool in the estimation of tumor extension and size.

Ultrasonography is a non-invasive modality, available at almost all institutions, not expensive, easily reproducible method of examining the larynx in infants and children, can be used safely during pregnancy in contrast to scan, portable and can be easily transferred to patients with difficult mobilization.

Ultrasound became a very important, widely used diagnostic tool for head and neck diseases; however, it was rarely used in the diagnosis of laryngeal diseases. This was because of the problem in visualization of laryngeal structures and thus in performing a complete laryngeal sonographic examination due to the acoustic extinction of the ultrasound by the ossified laryngeal cartilages .

Researchers have recently used color Doppler imaging to study the surface mucosal waves of the vocal folds. During the last several years high-frequency ultrasound became an effective diagnostic tool with small, flexible ultrasound transducers .

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients complaining of laryngeal lesions in adult adult age group between 18:65 years of both sexes. they are previously diagnosed by laryngoscope.

Description

Inclusion Criteria:

  • Patients complaining of laryngeal lesions in adult age group between age 18:65 years of both sexes.

Exclusion Criteria:

  • patients < 18 years
  • patients > 65 years
  • patients with spinal lesions who needs spinal immobilization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
role of ultrasound in diagnosis of laryngeal lesions
Time Frame: baseline
statistical study will be done between ultrasound and laryngoscope to assess sensitivity, specificity and accuracy of ultrasound in detecting lesions, differentiate benign from malignant lesions and reach final diagnosis of the laryngeal lesions.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (ACTUAL)

March 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 23, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US in laryngeal lesions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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