Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04777474
Study type	Interventional
Source	University Hospital Ostrava
Contact	Jirí Hyncica
Phone	0042059737
Email	jiri.hyncica@fno.cz
Status	Recruiting
Phase	N/A
Start date	May 15, 2021
Completion date	December 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400642` - Randomized Controlled Trial:High-flow Oxygen Therapy and Tracheal Intubation for Laryngeal Microsurgery	N/A
Recruiting	`NCT03429036` - Biospecimen Procurement for Head and Neck Disorders
Completed	`NCT00001552` - Characteristics of Idiopathic Familial Voice Disorders	N/A
Recruiting	`NCT06303180` - NIDCD Otolaryngology Clinical Protocol Biospecimen Bank
Recruiting	`NCT06316063` - Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study	N/A
Not yet recruiting	`NCT03450694` - Role of Ultrasound in Laryngeal Lesions	N/A
Recruiting	`NCT04369040` - Comparison of Two Ventilation Methods for Micro-Laryngeal Surgery	N/A
Recruiting	`NCT05198219` - Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults	N/A
Completed	`NCT01507792` - Iron Repletion in Chronic Cough and Iron Deficiency	N/A
Completed	`NCT04231344` - Laryngeal Disorders and GERD in Assiut University
Withdrawn	`NCT03214835` - CDx Biopsies for Detection of Laryngopharyngeal Reflux and Laryngeal Lesions	N/A
Not yet recruiting	`NCT06078527` - Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms