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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with peripheral pulmonary lesions | A total of 150 patients with peripheral pulmonary lesions who meet the inclusion and exclusion criteria will be prospectively enrolled, of which 100 patients will be used for the development of CLE interpretation criteria, and 50 patients will be used for the validation of the criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with peripheral pulmonary lesions scheduled for transbronchial lung biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun | Contact | +86-021-22200000 | 1511 | jysun1976@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
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| 6 months post-procedure |
| 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. | 6 months post-procedure |
| 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. | 6 months post-procedure |
| Incidence of complications | Complications mean a composite of procedure related adverse advents during and after the operation. | 1 month post-procedure |