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

Sponsor

University Hospital Ostrava (Other)

Overall Status

Recruiting

CT.gov ID

NCT04777474

Collaborator

(none)

150

Enrollment

Locations

Arm

30.6

Anticipated Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Laryngeal Disease Laryngeal Lesions Hypopharyngeal Lesions Suspected Laryngeal Cancer Suspected Hypopharyngeal Cancer Proven Laryngeal Cancer Proven Hypopharyngeal Cancer	Diagnostic Test: Enhanced contact endoscopy Diagnostic Test: Narrow band imaging Diagnostic Test: IMAGE1S imaging	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study subjects will be enrolled into one study group.The study subjects will be enrolled into one study group.

Masking:

None (Open Label)

Masking Description:

No masking is being used in the study

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Accuracy of enhanced contact endoscopy [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)
Sensitivity of enhanced contact endoscopy [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.
Specificity of enhanced contact endoscopy [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.
Positive predictive value of enhanced contact endoscopy [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.
Negative predictive value of enhanced contact endoscopy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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