- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777474
Benefit of Enhanced Contact Endoscopy in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Determination of Diagnostic Benefit of Enhanced Contact Endoscopy (ECE) in Pre-histological Diagnosis of Laryngeal and Hypopharyngeal Mucosal Lesions
Study Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
Study Locations
-
-
-
Hradec Králové, Czechia
- Recruiting
- University Hospital Hradec Kralove
-
Contact:
- Anna Švejdová, MD
- Phone Number: 3 221 0042049583
- Email: anna.svejdova@fnhk.cz
-
Principal Investigator:
- Anna Švejdová, MD
-
-
Moravian-Silesian Region
-
Ostrava, Moravian-Silesian Region, Czechia, 70852
- Recruiting
- University Hospital Ostrava
-
Contact:
- Jiří Hynčica
- Phone Number: 2587 0042059737
- Email: jiri.hyncica@fno.cz
-
Principal Investigator:
- Peter Kántor, MD
-
Sub-Investigator:
- Lucia Staníková, MD,Ph.D.
-
Sub-Investigator:
- Karol Zeleník, Assoc.Prof.,MD,Ph.D.,MBA
-
Sub-Investigator:
- Pavel Komínek, Prof.,MD,Ph.D.,MBA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced contact endoscopy
The study subjects will undergo enhanced contact endoscopy
|
The study subjects will undergo enhanced contact endoscopy - studied imaging technique
The study subjects will undergo narrow band imaging - comparator procedure
The study subjects will undergo IMAGE1S imaging - comparator procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
|
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)
|
Sensitivity of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
|
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)
|
Specificity of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
|
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)
|
Positive predictive value of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
|
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)
|
Negative predictive value of enhanced contact endoscopy
Time Frame: Procedure (During the examination under general anaesthesia)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Kántor, MD, University Hospital Ostrava
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23/RVO-FNOs/2020 (Other Grant/Funding Number: University Hospital Ostrava)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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