Clinical trial NCT04777474: Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Official title: Determination of Diagnostic Benefit of Enhanced Contact Endoscopy (ECE) in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Disease
Laryngeal Lesions
Hypopharyngeal Lesions
Suspected Laryngeal Cancer
Suspected Hypopharyngeal Cancer
Proven Laryngeal Cancer
Proven Hypopharyngeal Cancer
Keywords: laryngeal cancer
hypopharyngeal cancer
laryngeal disease
enhanced contact endoscopy
narrow band imaging
IMAGE1S method
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study subjects will be enrolled into one study group.
Primary purpose: DIAGNOSTIC

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of enhanced contact endoscopy
timeFrame: Procedure (During the examination under general anaesthesia)
measure: Sensitivity of enhanced contact endoscopy
timeFrame: Procedure (During the examination under general anaesthesia)
measure: Specificity of enhanced contact endoscopy
timeFrame: Procedure (During the examination under general anaesthesia)
measure: Positive predictive value of enhanced contact endoscopy
timeFrame: Procedure (During the examination under general anaesthesia)
measure: Negative predictive value of enhanced contact endoscopy
timeFrame: Procedure (During the examination under general anaesthesia)
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
Study officials:
affiliation: University Hospital Ostrava
name: Peter Kántor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puxeddu R, Sionis S, Gerosa C, Carta F. Enhanced contact endoscopy for the detection of neoangiogenesis in tumors of the larynx and hypopharynx. Laryngoscope. 2015 Jul;125(7):1600-6. doi: 10.1002/lary.25124. Epub 2015 Jan 13.
citation: Mehlum CS, Dossing H, Davaris N, Giers A, Grontved AM, Kjaergaard T, Moller S, Godballe C, Arens C. Interrater variation of vascular classifications used in enhanced laryngeal contact endoscopy. Eur Arch Otorhinolaryngol. 2020 Sep;277(9):2485-2492. doi: 10.1007/s00405-020-06000-z. Epub 2020 Apr 30.