Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy

Study Overview
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Brief Summary
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To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.

Detailed Description
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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.

Official Title
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The Diagnosis of Laryngeal Lesions Using the Probe-based Confocal Laser Endomicroscopy in Vivo

Conditions
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Laryngeal Leiomyoma, Probe-based Confocal Laser Endomicroscopy

Intervention / Treatment
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* Diagnostic Test: Confocal Laser Endomicroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18≤Male or female age ≤85 years old; patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery; Willing and able to comply with study procedures and provide written informed consent to participate in the study. Exclusion Criteria: Male or female <18 years old, or Male or female >85 years; The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination; The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery. The patient has a history of allergies to drugs or food. The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein; Lactation or pregnant women. Refusal to sign the informed consent form. Others who do not take this test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal mucosa<br>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. | Diagnostic Test: Confocal Laser Endomicroscopy<br>* 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.<br>|
| non-malignant lesions<br>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. | Diagnostic Test: Confocal Laser Endomicroscopy<br>* 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.<br>|
| malignant lesions<br>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. | Diagnostic Test: Confocal Laser Endomicroscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the image analysis by machine learning | Quantitative image features are calculated in the pCLE images by machine learning | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probe-based confocal laser endomicroscopy, Optical biopsy