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

Eye & ENT Hospital of Fudan University

Status: Unknown

Conditions: Laryngeal Leiomyoma; Probe-based Confocal Laser Endomicroscopy

Treatments: Diagnostic Test: Confocal Laser Endomicroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04139889

20170601

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

normal mucosa

Description:

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.

Treatment:

Diagnostic Test: Confocal Laser Endomicroscopy

non-malignant lesions

Description:

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.

Treatment:

Diagnostic Test: Confocal Laser Endomicroscopy

malignant lesions

Description:

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.

Treatment:

Diagnostic Test: Confocal Laser Endomicroscopy