Confocal Laser Endomicroscopy in the Diagnosis of Peripheral Pulmonary Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Pulmonary Lesions
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of the study is to describe confocal laser endomicroscopy (CLE) interpretation criteria for different types of peripheral pulmonary lesions (PPLs), with histopathological correlation, and to perform the validation of these criteria.
Detailed Description
CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial lung biopsy, CLE has the potential to provide real-time non-invasive diagnosis of PPLs ("optical biopsy"). In this study, we will obtain CLE images within the target lesion before taking a biopsy during transbronchial lung biopsy of PPLs. We will compare the results of the "optical biopsy" with the corresponding histopathological results and develop CLE interpretation criteria for different types of PPLs. In addition, we will perform the validation of these criteria to evaluate the ability of CLE to discriminate between benign and malignant PPLs.
Investigators
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients older than 18 years.
- •Chest CT shows peripheral pulmonary lesions (peripheral pulmonary lesions are lesions beyond the segmental bronchi that are invisible during bronchoscopy), and transbronchial biopsy is considered necessary and feasible.
- •Patients who have good compliance and sign informed consent.
Exclusion Criteria
- •Patients with known allergy for fluorescein.
- •Pregnant or lactating women.
- •Patients with contraindications of bronchoscopy.
- •The investigators believe that patient has other conditions that are not suitable for the study.
Outcomes
Primary Outcomes
Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs
Time Frame: 6 months post-procedure
Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed CLE interpretation criteria divided by the total number of lesions.
Secondary Outcomes
- Incidence of complications(1 month post-procedure)
- Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs(6 months post-procedure)
- positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs(6 months post-procedure)
- Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs(6 months post-procedure)