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

NCT ID: NCT04139889

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-12-21

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.

Conditions

Laryngeal Leiomyoma; Probe-based Confocal Laser Endomicroscopy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Confocal Laser Endomicroscopy

Intervention Type: 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.

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.

Confocal Laser Endomicroscopy

Intervention Type: 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

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.

Confocal Laser Endomicroscopy

Intervention Type: 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.

Interventions

Confocal 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huawei Li, PhD &MD

Role: STUDY_CHAIR

Otorhinolaryngology Department of Eye & ENT Hospital, Fudan University

Locations

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lingjie Wu, PhD &MD

Role: CONTACT

wulingjie116@163.com

+86-15821574627

Facility Contacts

Lingjie Wu

Role: primary

Other Identifiers

20170601

Identifier Type: -

Identifier Source: org_study_id