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AzTrials

Laryngeal DiseaseNCT04777474

Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions

A study testing Enhanced contact endoscopy, Narrow band imaging and IMAGE1S imaging in people with Laryngeal Disease and Laryngeal Lesions, run by University Hospital Ostrava at 2 sites in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The focus of the study is to verify the role of enhanced contact endoscopy in early identification of high-risk vascular patterns of precancerous and malignant mucosal changes in ear-nose-throat (ENT) patients, in comparison with other standard imaging techniques. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Enhanced contact endoscopy, Narrow band imaging and IMAGE1S imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesCzechia
Study dates
15 May 2021to Dec 2023
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 and older
  • patients scheduled for direct hypopharyngoscopy and laryngoscopy in general anaesthesia
  • benign laryngeal and hypoharyngeal disease/laryngeal and hypopharyngeal lesions of uncertain biologic behaviour (leukoplakia, erythroplakia, keratosis)
  • patients with suspicious macroscopical lesion found during ENT examination/patients with histologically confirmed metastasis of carcinoma in neck lymph node with unknown primary origin of the tumour
  • patients with recurrence of malign tumour in hypopharynx or larynx
  • patients after radiotherapy indicated for follow up examination under general anaesthesia
  • patients with persistent non-specific problems (hoarseness, swallowing problems etc.) indicated to direct laryngohypopharyngoscopy due to diagnostic purposes

Who cannot join

  • age - younger than 17 years
  • refusal to join the study

Trial locations and contacts

2 sites in 1 country.

Jiří Hynčica contact

0042059737 ext. 2587

jiri.hyncica@fno.cz

Czechia2 sites, 2 recruiting

  • University Hospital Hradec Králové

    Hradec Králové

    Anna Švejdová, MD, 0042049583 ext. 3 221, anna.svejdova@fnhk.cz

    Anna Švejdová, MD

    Recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

    Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz

    Peter Kántor, MD

    Recruiting

Other trials in Czechia

About this study

Official title: Determination of Diagnostic Benefit of Enhanced Contact Endoscopy (ECE) in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions

The focus of the study is to verify the role of enhanced contact endoscopy in early identification of high-risk vascular patterns of precancerous and malignant mucosal changes in ear-nose-throat (ENT) patients, in comparison with other standard imaging techniques.

Read the detailed description

Endoscopy methods are inseparable part in diagnostics of patients with head and neck cancer. Nowadays ENT surgeons are offered a wide variety of endoscopy methods. The methods that caused revolution in early diagnostics of head and neck cancer were advanced imagining endoscopy methods such as NBI or IMAGE1S.

The new only recently introduced method is enhanced contact endoscopy, which uses a combination of advanced imagining, such as NBI or IMAGE1S, with rigid microlaryngoscope. It is believed that this technology has the potential to visualise vascular patterns of precancerous and malignant mucosal changes even better than narrow-band imaging (NBI) and IMAGE1S. This improvement in diagnostics helps with early identification of high-risk lesions and moves us closer to the concept of pre-histological diagnostics, which helps to accelerate making final diagnosis, which leads to prompt treatment.

Study protocol:

  • anamnestic questionnaire (age, sex, weight, height, smoking, alcohol, reflux disease)
  • Reflux Symptom Index (RSI) questionnaire
  • endoscopy in white light in local anaesthesia with evaluation:
  • character of the lesion (benign, Reinke edema, cyst, polyp, chronic laryngitis/pharyngitis, leukoplakia, erythroplakia, malignity)
  • bleeding or ulceration on the surface of the lesion
  • endoscopy with NBI endoscope in local anesthesia with evaluation:
  • mucosa vascularization according to the ELS classification
  • size of the lesion in compare to endoscopy in white light in local anesthesia
  • occurrence of new lesions in compare to endoscopy in white light in local anesthesia
  • endoscopy in white light in general anesthesia during microlaryngoscopy
  • character of the lesion (benign, Reinkes edema, cyst, polyp, chronic laryngitis/pharyngitis, leukoplakia, erythroplakia, malignity)
  • bleeding or ulceration on the surface of the lesion
  • size of the lesion in compare to endoscopy in white light in local anesthesia
  • occurence of new lesions when compared with endoscopy in white light in local anesthesia
  • endoscopy in NBI or IMAGE1S in general anesthesia during microlaryngoscopy
  • mucosa vascularization according to the ELS classification
  • size of the lesion in compare to endoscopy in white light in local anesthesia
  • occurence of new lesions in compare to endoscopy in white light in local anesthesia
  • enhanced contact endoscopy (ECE) in NBI or IMAGE1S in general anesthesia during microlaryngoscopy
  • mucosa vascularization according to the ELS and Puxxedu classification
  • size of the lesion in compare to endoscopy in white light and NBI/ IMAGE1S in general anesthesia
  • occurence of new lesions in compare to endoscopy in white light and NBI/

IMAGE1S in general anesthesia

  • histology examination with determination of final diagnosis
  • benign lesion
  • mild dysplasia
  • severe dysplasia
  • carcinoma in situ
  • invasive cancer
Being tested
Enhanced contact endoscopy, Narrow band imaging, IMAGE1S imaging
Keywords
laryngeal cancer, hypopharyngeal cancer, laryngeal disease, enhanced contact endoscopy, narrow band imaging, IMAGE1S method
Medical subject headings
Laryngeal Diseases, Laryngeal Neoplasms, Hypopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced contact endoscopyDiagnostic test

    The study subjects will undergo enhanced contact endoscopy - studied imaging technique

  • Narrow band imagingDiagnostic test

    The study subjects will undergo narrow band imaging - comparator procedure

  • IMAGE1S imagingDiagnostic test

    The study subjects will undergo IMAGE1S imaging - comparator procedure

Study groups in NCT04777474
Study groupRoleWhat they receive
Enhanced contact endoscopyExperimentalThe study subjects will undergo enhanced contact endoscopy
Receives: Diagnostic Test: Enhanced contact endoscopy; Diagnostic Test: Narrow band imaging; Diagnostic Test: IMAGE1S imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of enhanced contact endoscopy

    The accuracy of enhanced contact endoscopy will be observed (size of lesions in mm when compared with the other standard techniques)

    Measured: Procedure (During the examination under general anaesthesia)

  2. Sensitivity of enhanced contact endoscopy

    The sensitivity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

    Measured: Procedure (During the examination under general anaesthesia)

  3. Specificity of enhanced contact endoscopy

    The specificity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

    Measured: Procedure (During the examination under general anaesthesia)

  4. Positive predictive value of enhanced contact endoscopy

    The positive predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

    Measured: Procedure (During the examination under general anaesthesia)

  5. Negative predictive value of enhanced contact endoscopy

    The negative predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.

    Measured: Procedure (During the examination under general anaesthesia)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start15 May 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
The study subjects will be enrolled into one study group.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777474
Sponsor's protocol ID
23/RVO-FNOs/2020
Other IDs
23/RVO-FNOs/2020
Status last verified
Dec 2022
First submitted
23 Feb 2021
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Publications

  • Puxeddu R, Sionis S, Gerosa C, Carta F. Enhanced contact endoscopy for the detection of neoangiogenesis in tumors of the larynx and hypopharynx. Laryngoscope. 2015 Jul;125(7):1600-6. doi: 10.1002/lary.25124. Epub 2015 Jan 13.

    PubMed 25582112

  • Mehlum CS, Dossing H, Davaris N, Giers A, Grontved AM, Kjaergaard T, Moller S, Godballe C, Arens C. Interrater variation of vascular classifications used in enhanced laryngeal contact endoscopy. Eur Arch Otorhinolaryngol. 2020 Sep;277(9):2485-2492. doi: 10.1007/s00405-020-06000-z. Epub 2020 Apr 30.

    PubMed 32350646

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced contact endoscopy, Narrow band imaging and IMAGE1S imaging in people with Laryngeal Disease and Laryngeal Lesions, run by University Hospital Ostrava at 2 sites in Czechia.

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 7 inclusion and 2 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of enhanced contact endoscopy (time frame: Procedure (During the examination under general anaesthesia)). The study lists 5 primary outcomes in all. 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 NCT04777474, which also lists 2 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 7 Dec 2022.

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