Laryngeal DiseaseNCT03450694
Role of Ultrasound in Laryngeal Lesions
An observational study of Laryngeal Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngeal Disease
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients complaining of laryngeal lesions in adult age group between age 18:65 years of both sexes.
Who cannot join
- patients < 18 years
- patients > 65 years
- patients with spinal lesions who needs spinal immobilization
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Laryngeal Disease
- Being tested
- ultrasound
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
ultrasound is a non-invasive and not expensive method, availiable at almost all institutions.
What is being measured
The primary outcome is the main question the study is designed to answer.
role of ultrasound in diagnosis of laryngeal lesions
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Laryngeal DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat-Alllah Samy Abdelaziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450694
- Sponsor's protocol ID
- US in laryngeal lesions
- Status last verified
- Feb 2018
- First submitted
- 23 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agrawal N, Ha PK. Management of early-stage laryngeal cancer. Otolaryngol Clin North Am. 2008 Aug;41(4):757-69, vi-vii. doi: 10.1016/j.otc.2008.01.014.
PubMed 185709573. 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.
Arens C, Eistert B, Glanz H, Waas W. Endolaryngeal high-frequency ultrasound. Eur Arch Otorhinolaryngol. 1998;255(5):250-5. doi: 10.1007/s004050050052.
PubMed 9638467Muscat JE, Liu HP, Livelsberger C, Richie JP Jr, Stellman SD. The nicotine dependence phenotype, time to first cigarette, and larynx cancer risk. Cancer Causes Control. 2012 Mar;23(3):497-503. doi: 10.1007/s10552-012-9909-x. Epub 2012 Feb 25.
PubMed 22367700Shao J, Stern J, Wang ZM, Hanson D, Jiang J. Clinical evaluation of 70 degrees and 90 degrees laryngeal telescopes. Arch Otolaryngol Head Neck Surg. 2002 Aug;128(8):941-4. doi: 10.1001/archotol.128.8.941.
PubMed 12162775Shau YW, Wang CL, Hsieh FJ, Hsiao TY. Noninvasive assessment of vocal fold mucosal wave velocity using color doppler imaging. Ultrasound Med Biol. 2001 Nov;27(11):1451-60. doi: 10.1016/s0301-5629(01)00453-7.
PubMed 11750743Torre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends--An Update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16-27. doi: 10.1158/1055-9965.EPI-15-0578. Epub 2015 Dec 14.
PubMed 2666788612. Wendy, D., 2007. Laryngeal ultrasound provides non invasive assessment of vocal fold lesions. Ann Otol Rhinol Laryngol, 171, pp.631-647.
Wolf M, Primov-Fever A, Amir O, Jedwab D. The feasibility of rigid stroboscopy in children. Int J Pediatr Otorhinolaryngol. 2005 Aug;69(8):1077-9. doi: 10.1016/j.ijporl.2005.03.004. Epub 2005 Mar 31.
PubMed 16005350
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound in Diagnosis of Laryngeal Lesions
- ClinicalTrials.gov ID
- NCT03450694
- Acronym / sponsor ID
- US in laryngeal lesions
- Conditions
- Laryngeal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients complaining of laryngeal lesions in adult age group between age 18:65 years of both sexes.
Key exclusion criteria (3 listed)
- patients < 18 years
- patients > 65 years
- patients with spinal lesions who needs spinal immobilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundultrasound is a non-invasive and not expensive method, availiable at almost all institutions. | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Background: PubMed 18570957Agrawal N, Ha PK. Management of early-stage laryngeal cancer. Otolaryngol Clin North Am. 2008 Aug;41(4):757-69, vi-vii. doi: 10.1016/j.otc.2008.01.014.
- Background3. 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.
- BackgroundAmerican Cancer Society, 2008. Cancer facts & figures. The Society.
- Background: PubMed 9638467Arens C, Eistert B, Glanz H, Waas W. Endolaryngeal high-frequency ultrasound. Eur Arch Otorhinolaryngol. 1998;255(5):250-5. doi: 10.1007/s004050050052.
- Background: PubMed 22367700Muscat JE, Liu HP, Livelsberger C, Richie JP Jr, Stellman SD. The nicotine dependence phenotype, time to first cigarette, and larynx cancer risk. Cancer Causes Control. 2012 Mar;23(3):497-503. doi: 10.1007/s10552-012-9909-x. Epub 2012 Feb 25.
- Background: PubMed 12162775Shao J, Stern J, Wang ZM, Hanson D, Jiang J. Clinical evaluation of 70 degrees and 90 degrees laryngeal telescopes. Arch Otolaryngol Head Neck Surg. 2002 Aug;128(8):941-4. doi: 10.1001/archotol.128.8.941.
- Background: PubMed 11750743Shau YW, Wang CL, Hsieh FJ, Hsiao TY. Noninvasive assessment of vocal fold mucosal wave velocity using color doppler imaging. Ultrasound Med Biol. 2001 Nov;27(11):1451-60. doi: 10.1016/s0301-5629(01)00453-7.
- Background: PubMed 26667886Torre LA, Siegel RL, Ward EM, Jemal A. Global Cancer Incidence and Mortality Rates and Trends--An Update. Cancer Epidemiol Biomarkers Prev. 2016 Jan;25(1):16-27. doi: 10.1158/1055-9965.EPI-15-0578. Epub 2015 Dec 14.
- Background12. Wendy, D., 2007. Laryngeal ultrasound provides non invasive assessment of vocal fold lesions. Ann Otol Rhinol Laryngol, 171, pp.631-647.
- Background: PubMed 16005350Wolf M, Primov-Fever A, Amir O, Jedwab D. The feasibility of rigid stroboscopy in children. Int J Pediatr Otorhinolaryngol. 2005 Aug;69(8):1077-9. doi: 10.1016/j.ijporl.2005.03.004. Epub 2005 Mar 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact menna samy, resident (+201098989868, mennatallahsamy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of ultrasound in diagnosis of laryngeal lesions (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03450694, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.