NCT04777474

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Laryngeal Disease
• Laryngeal Lesions
• Hypopharyngeal Lesions
• Suspected Laryngeal Cancer
• Suspected Hypopharyngeal Cancer
• Proven Laryngeal Cancer
• Proven Hypopharyngeal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-15
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-03-02
• Last updated: 2022-12-07

Locations

2 sites across 1 country: Czechia