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To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.
In this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pCLE in the diagnosis of laryngeal cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal mucosa | Flat and relatively uniform polygonal epithelial cells with alternating dark and light bands were noted in pCLE images of normal mucosa after intravenous injecting 10% fluorescein. |
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| non-malignant lesions | An unorganized tissue architecture, irregular cells (difference of cell shape, color and size), slightly intensified fluorescein leakage, and vessels not assessable were found in the lymphoid hyperplasia of non-malignant lesions after intravenous injecting 10% fluorescein. |
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| malignant lesions | pCLE images of malignant lesions were associated with crowded unorganized tissue architecture (a dark-gray background without identification of mucosal structures), irregular cells like cell clusters, amplified fluorescein leakage, and irregular vessels changes after intravenous injecting 10% fluorescein. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confocal Laser Endomicroscopy | Diagnostic Test | Confocal laser microendoscopy (CLE) as a new non-invasive imaging technique can be used for "optical biopsy", which can perform real-time microscopic information of tissue in vivo at cellular level with resolutions up to 1μm and magnifications up to 1000 times. CLE is now being increasingly used with very promising results in gastroenterology, especially in the diagnostic investigation of Barret's esophagus, stomach cancer, colorectal cancer and various lesions of the biliary tract. With an intravenous injection of fluorescein, probe-based CLE (pCLE: GastroFlex probe with the Cellvizio laser system, Mauna Technologies, Paris, France) allows us to view the interstitial spaces, cells, and small capillaries in a window of 240 μm and to a depth of 60 μm. |
| Measure | Description | Time Frame |
|---|---|---|
| pCLE diagnostic classification | Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| the image analysis by machine learning | Quantitative image features are calculated in the pCLE images by machine learning | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with suspicious unidentified lesions were collected in this study in Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, who need to be underwent microscopic laryngoscopy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingjie Wu, PhD &MD | Contact | +86-15821574627 | wulingjie116@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huawei Li, PhD &MD | Otorhinolaryngology Department of Eye & ENT Hospital, Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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