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| ID | Type | Description | Link |
|---|---|---|---|
| 23/RVO-FNOs/2020 | Other Grant/Funding Number | University Hospital Ostrava |
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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.
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:
IMAGE1S in general anesthesia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced contact endoscopy | Experimental | The study subjects will undergo enhanced contact endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced contact endoscopy | Diagnostic Test | The study subjects will undergo enhanced contact endoscopy - studied imaging technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Peter Kántor, MD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25582112 | Background | 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. | |
| 32350646 | Background | 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. |
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There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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The study subjects will be enrolled into one study group.
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No masking is being used in the study
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| Narrow band imaging | Diagnostic Test | The study subjects will undergo narrow band imaging - comparator procedure |
|
| IMAGE1S imaging | Diagnostic Test | The study subjects will undergo IMAGE1S imaging - comparator procedure |
|
| University Hospital Hradec Králové | Recruiting | Hradec Králové | Czechia |
|
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D007822 | Laryngeal Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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