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

  • STATUS
    Recruiting
  • End date
    Dec 8, 2023
  • participants needed
    150
  • sponsor
    University Hospital Ostrava
Updated on 8 July 2021

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.

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

Details
Condition Suspected Hypopharyngeal Cancer, Proven Hypopharyngeal Cancer, Laryngeal disorder, Proven Laryngeal Cancer, Hypopharyngeal Lesions, Suspected Laryngeal Cancer, Laryngeal Lesions
Treatment Narrow Band Imaging, Enhanced contact endoscopy, IMAGE1S imaging
Clinical Study IdentifierNCT04777474
SponsorUniversity Hospital Ostrava
Last Modified on8 July 2021

Eligibility

Yes No Not Sure

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
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