Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Primary Purpose
Laryngeal Disease, Laryngeal Lesions, Hypopharyngeal Lesions
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Enhanced contact endoscopy
Narrow band imaging
IMAGE1S imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Laryngeal Disease focused on measuring laryngeal cancer, hypopharyngeal cancer, laryngeal disease, enhanced contact endoscopy, narrow band imaging, IMAGE1S method
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
Sites / Locations
- University Hospital OstravaRecruiting
- University Hospital Hradec KrálovéRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enhanced contact endoscopy
Arm Description
The study subjects will undergo enhanced contact endoscopy
Outcomes
Primary Outcome Measures
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)
Sensitivity of enhanced contact endoscopy
The sensitivity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Specificity of enhanced contact endoscopy
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
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
The negative predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Secondary Outcome Measures
Full Information
NCT ID
NCT04777474
First Posted
February 23, 2021
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT04777474
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study subjects will be enrolled into one study group.
Masking
None (Open Label)
Masking Description
No masking is being used in the study
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enhanced contact endoscopy
Arm Type
Experimental
Arm Description
The study subjects will undergo enhanced contact endoscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
Enhanced contact endoscopy
Intervention Description
The study subjects will undergo enhanced contact endoscopy - studied imaging technique
Intervention Type
Diagnostic Test
Intervention Name(s)
Narrow band imaging
Intervention Description
The study subjects will undergo narrow band imaging - comparator procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
IMAGE1S imaging
Intervention Description
The study subjects will undergo IMAGE1S imaging - comparator procedure
Primary Outcome Measure Information:
Title
Accuracy of enhanced contact endoscopy
Description
The accuracy of enhanced contact endoscopy will be observed (size of lesions in mm when compared with the other standard techniques)
Time Frame
Procedure (During the examination under general anaesthesia)
Title
Sensitivity of enhanced contact endoscopy
Description
The sensitivity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Time Frame
Procedure (During the examination under general anaesthesia)
Title
Specificity of enhanced contact endoscopy
Description
The specificity of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Time Frame
Procedure (During the examination under general anaesthesia)
Title
Positive predictive value of enhanced contact endoscopy
Description
The positive predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Time Frame
Procedure (During the examination under general anaesthesia)
Title
Negative predictive value of enhanced contact endoscopy
Description
The negative predictive value of enhanced contact endoscopy in making pre-histological diagnosis using final histopathology result. will be observed.
Time Frame
Procedure (During the examination under general anaesthesia)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kántor, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Peter Kántor, MD
First Name & Middle Initial & Last Name & Degree
Lucia Staníková, MD,Ph.D.
First Name & Middle Initial & Last Name & Degree
Karol Zeleník, Assoc.Prof.,MD,Ph.D.,MBA
First Name & Middle Initial & Last Name & Degree
Pavel Komínek, Prof.,MD,Ph.D.,MBA
Facility Name
University Hospital Hradec Králové
City
Hradec Králové
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Švejdová, MD
Phone
0042049583
Ext
3 221
Email
anna.svejdova@fnhk.cz
First Name & Middle Initial & Last Name & Degree
Anna Švejdová, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Citations:
PubMed Identifier
25582112
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.
Results Reference
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PubMed Identifier
32350646
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.
Results Reference
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Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
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