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

• Conditions: Laryngeal Leiomyoma; Probe-based 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

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