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Role of Ultrasound in Laryngeal Lesions

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ClinicalTrials.gov Identifier: NCT03450694
Recruitment Status : Unknown
Verified February 2018 by Mennat-Alllah Samy Abdelaziz, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
Mennat-Alllah Samy Abdelaziz, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Laryngeal Disease Device: ultrasound

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 .

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Ultrasound in Diagnosis of Laryngeal Lesions
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Intervention Details:
  • Device: ultrasound
    ultrasound is a non-invasive and not expensive method, availiable at almost all institutions.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450694

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Contact: menna samy, resident +201098989868 mennatallahsamy@yahoo.com
Contact: hossam galal, assistant professor 01014269335 h.elmalah@yahoo.com

Sponsors and Collaborators
Assiut University
3. Arruti, A. and Poumayrac, D.M., 2010. Larynx ultrasonography: an alternative technique in the evaluation of the aero-digestive crossroad. Rev Imagenol, 14(1), pp.30-6.
American Cancer Society, 2008. Cancer facts & figures. The Society.
12. Wendy, D., 2007. Laryngeal ultrasound provides non invasive assessment of vocal fold lesions. Ann Otol Rhinol Laryngol, 171, pp.631-647.

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Responsible Party: Mennat-Alllah Samy Abdelaziz, mennat-Allah Samy, Assiut University
ClinicalTrials.gov Identifier: NCT03450694    
Other Study ID Numbers: US in laryngeal lesions
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases