Optical Biopsy for Peripheral Pulmonary Lesions
ConditionPeripheral Pulmonary Lesions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Chest Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with peripheral pulmonary lesions scheduled for transbronchial lung biopsy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Patients with peripheral pulmonary lesions
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs
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.
Time frame
6 months post-procedureSecondary outcomes
1
Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs
Sensitivity is defined as the number of lesions correctly identified as malignant using our proposed CLE interpretation criteria divided by the total number of malignant lesions. Specificity is defined as the number of lesions correctly identified as benign using our proposed CLE interpretation criteria divided by the total number of benign lesions.
Time frame
6 months post-procedure2
positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs
The positive predictive value is the percentage of true malignant lesions among all lesions identified as malignant using our proposed CLE interpretation criteria. The negative predictive value is the percentage of true benign lesions among all lesions identified as benign using our proposed CLE interpretation criteria.
Time frame
6 months post-procedure3
Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs
Different types of PPLs include different types of common malignant PPLs (e.g., adenocarcinoma, squamous cell carcinoma, small cell lung carcinoma, etc.) and different types of common benign PPLs (e.g., inflammation, tuberculosis, fungal infection, etc.). Diagnostic accuracy is defined as the number of lesions correctly identified as a specific disease using our proposed CLE interpretation criteria divided by the total number of lesions.
Time frame
6 months post-procedure4
Incidence of complications
Complications mean a composite of procedure related adverse advents during and after the operation.
Time frame
1 month post-procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: