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

Laryngeal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04777474
• Other study ID #: 23/RVO-FNOs/2020
• Secondary ID: 23/RVO-FNOs/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Enhanced contact endoscopy
The study subjects will undergo enhanced contact endoscopy - studied imaging technique
• Narrow band imaging
The study subjects will undergo narrow band imaging - comparator procedure
• IMAGE1S imaging
The study subjects will undergo IMAGE1S imaging - comparator procedure

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Králové	Hradec Králové
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of enhanced contact endoscopy	The accuracy of enhanced contact endoscopy will be observed (size of lesions in mm when compared with the other standard techniques)	Procedure (During the examination under general anaesthesia)
Primary	Sensitivity of enhanced contact endoscopy	The sensitivity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.	Procedure (During the examination under general anaesthesia)
Primary	Specificity of enhanced contact endoscopy	The specificity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.	Procedure (During the examination under general anaesthesia)
Primary	Positive predictive value of enhanced contact endoscopy	The positive predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.	Procedure (During the examination under general anaesthesia)
Primary	Negative predictive value of enhanced contact endoscopy	The negative predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.	Procedure (During the examination under general anaesthesia)