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

NCT04139889 | Unknown DMC

• 1 other identifier: 20170601
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laryngeal Leiomyoma; Probe-based Confocal Laser Endomicroscopy

Keywords

Probe-based confocal laser endomicroscopy; Optical biopsy

Outcome Measures

Primary Outcomes (1)

• pCLE diagnostic classification

  Evaluation of pCLE diagnostic performance for the diagnosis of Laryngeal Lesions when associated with other diagnostic information.

  6 months

Secondary Outcomes (1)

• the image analysis by machine learning

  6 months

Study Arms (3)

normal mucosa

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

non-malignant lesions

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

malignant lesions

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

Interventions

Confocal Laser Endomicroscopy DIAGNOSTIC_TEST

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.

malignant lesions; non-malignant lesions; normal mucosa

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with suspicious unidentified lesions were collected in this study in Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, who need to be underwent microscopic laryngoscopy.

You may qualify if:

• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Study Officials

• Huawei Li, PhD &MD

  Otorhinolaryngology Department of Eye & ENT Hospital, Fudan University

  STUDY CHAIR

Central Study Contacts

Lingjie Wu, PhD &MD

CONTACT

+86-15821574627; wulingjie116@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 25, 2019
• Study Start: June 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: December 21, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)