Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777474
Status:
RECRUITING
Last Update Posted:
2022-12-07
First Post:
2021-02-23
Brief Title:
Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Determination of Diagnostic Benefit of Enhanced Contact Endoscopy ECE in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 laryngitispharyngitis 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 laryngitispharyngitis 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
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 laryngitispharyngitis 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 laryngitispharyngitis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23RVO-FNOs2020 | OTHER_GRANT | University Hospital Ostrava | None |