Laryngeal Leiomyoma, Probe-based Confocal Laser Endomicroscopy
Conditions
Keywords
Probe-based confocal laser endomicroscopy, Optical biopsy
Brief summary
To evaluate the diagnosis of laryngeal lesions using the Probe-based Confocal Laser Endomicroscopy in vivo.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTConfocal Laser Endomicroscopy
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.
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 18≤Male or female age ≤85 years old; 2. patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery; 3. Willing and able to comply with study procedures and provide written informed consent to participate in the study.
Exclusion criteria
1. Male or female \<18 years old, or Male or female \>85 years; 2. The patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination; 3. The patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery. 4. The patient has a history of allergies to drugs or food. 5. The patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein; 6. Lactation or pregnant women. 7. Refusal to sign the informed consent form. 8. Others who do not take this test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCLE diagnostic classification | 6 months | Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the image analysis by machine learning | 6 months | Quantitative image features are calculated in the pCLE images by machine learning |
Countries
China
Contacts
Primary ContactLingjie Wu, PhD &MD
Outcome results
None listed