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

• Conditions: Laryngeal Leiomyoma; Probe-based Confocal Laser Endomicroscopy
• Interventions: Diagnostic Test: Confocal Laser Endomicroscopy

• Registration Number: NCT04139889
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Primary Completion: 2019-11-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-04
• Last Update Posted: 2020-01-07
• Study Completion: 2020-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-malignant lesions	Confocal Laser Endomicroscopy	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.
normal mucosa	Confocal Laser Endomicroscopy	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.
malignant lesions	Confocal Laser Endomicroscopy	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.

Primary Outcome Measures

Name	Time	Method
pCLE diagnostic classification	6 months	Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.

Secondary Outcome Measures

Name	Time	Method
the image analysis by machine learning	6 months	Quantitative image features are calculated in the pCLE images by machine learning

Trial Locations

Locations (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China