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

December 6, 2022 updated by: University Hospital Ostrava

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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 Locations

  • Czechia
      • Hradec Králové, Czechia
        • Recruiting
        • University hospital Hradec Králové
        • Contact:
        • Principal Investigator:
          • Anna Švejdová, MD
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Peter Kántor, MD
        • Sub-Investigator:
          • Lucia Staníková, MD,Ph.D.
        • Sub-Investigator:
          • Karol Zeleník, Assoc.Prof.,MD,Ph.D.,MBA
        • Sub-Investigator:
          • Pavel Komínek, Prof.,MD,Ph.D.,MBA

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced contact endoscopy
The study subjects will undergo enhanced contact endoscopy
Diagnostic test: Enhanced contact endoscopy
The study subjects will undergo enhanced contact endoscopy - studied imaging technique
Diagnostic test: Narrow band imaging
The study subjects will undergo narrow band imaging - comparator procedure
Diagnostic test: IMAGE1S imaging
The study subjects will undergo IMAGE1S imaging - comparator procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
The accuracy of enhanced contact endoscopy will be observed (size of lesions in mm when compared with the other standard techniques)
Procedure (During the examination under general anaesthesia)
Sensitivity of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
The sensitivity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Procedure (During the examination under general anaesthesia)
Specificity of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
The specificity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Procedure (During the examination under general anaesthesia)
Positive predictive value of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
The positive predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Procedure (During the examination under general anaesthesia)
Negative predictive value of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
The negative predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Procedure (During the examination under general anaesthesia)

Collaborators and Investigators

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

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Peter Kántor, MD, University Hospital Ostrava

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 (Actual)

May 15, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/RVO-FNOs/2020 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

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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