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To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.
The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal mucosa | Active Comparator | 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. |
|
| lymphoid hyperplasia | Experimental | 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 nasopharyngeal mucosa after intravenous injecting 10% fluorescein.. |
|
| nasopharyngeal carcinoma | Experimental | pCLE images of nasopharyngeal carcinoma, which was 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% fluorescein | Diagnostic Test | The nasopharyngeal lesions were first identified endoscopically by nasal endoscope. Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract. |
| Measure | Description | Time Frame |
|---|---|---|
| pCLE classification and scoring system | Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| the quantitative image analysis | Quantitative image features are calculated in the pCLE images | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huawei Li, Phd &MD | Contact | hwli@shmu.edu.cn | ||
| Lingjie Wu, MS & MD | Contact | wulingjie116@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huawei Li, Phd &MD | Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002294 | Carcinoma, Squamous Cell |