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

University Hospital Ostrava

Status

Enrolling

Conditions

Suspected Hypopharyngeal Cancer

Laryngeal Disease

Proven Laryngeal Cancer

Proven Hypopharyngeal Cancer

Laryngeal Lesions

Suspected Laryngeal Cancer

Hypopharyngeal Lesions

Treatments

Diagnostic Test: Narrow band imaging

Diagnostic Test: IMAGE1S imaging

Diagnostic Test: Enhanced contact endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04777474

23/RVO-FNOs/2020 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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