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The purpose of this study is to describe and validate confocal laser endomicroscopy(CLE) and rapid on-site evaluation(ROSE) interpretation criteria for different types of intrathoracic lymphadenopathy.
This is a single-arm, single-center and prospective study. Approximately 150 patients with intrathoracic lymphadenopathy will be included to receive CLE and ROSE for the diagnosis of the lesions. CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial biopsy, CLE has the potential to provide rea-lime non-invasive diagnosis of intrathoracic lymphadenopathy ('optical biopsy'). Rapid on-site evaluation (ROSE) is an important auxiliary technology for transbronchial biopsy, providing rapid cytopathological evaluation of specimens during operation and feedback on specimen quality and preliminary diagnosis of lesions. In this study, we will obtain CLE images and ROSE images of the target lesion . We will compare the results of the 'optical biopsy' and cytological evaluation with the corresponding histopathological results and develop CLE and ROSE interpretation criteria for different types of intrathoracic lymphadenopathy. In addition, we will perform the validation of these criteria to evaluate the ability of CLE and ROSE to discriminate between benign and malignant intrathoracic lymphadenopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with intrathoracic lymphadenopathy | Experimental | Approximately 150 patients with intrathoracic lymphadenopathy who meet the inclusion and exclusion criteria will be prospectively included. CLE and ROSE will be performed to diagnose the lesion. 100 patients will be used to establish CLE and ROSE interpretation criteria, and 50 patients will be used for criteria validation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLE and ROSE | Diagnostic Test | All patients undergo white light bronchoscopy after general anesthesia to rule out abnormalities in the lumen and clear the airways. After locating the target lymph node using convex probe endobronchial ultrasound (CP-EBUS), the target lymph node is routinely explored using the grayscale, blood flow and elastography modes CP-EBUS. Puncture is performed using a puncture needle under the guidance of CP-EBUS, and then the CLE probe is inserted into the target lymph node through the puncture needle. Sodium fluorescein is intravenously injected before CLE imaging. Under the guidance of CP-EBUS, the CLE probe is slowly moved to examine the target lesion. According to the real-time CLE images, the ideal biopsy location is identified. After the CLE examination is completed, cryobiopsy is performed at the ideal biopsy location confirmed by CLE under the guidance of CP-EBUS. After sampling, ROSE of the samples is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy | Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed CLE and ROSE interpretation criteria divided by the total number of lesions. | 6 month post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, positive predictive value and negative predictive value of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy | Sensitivity is defined as the number of lesions correctly identified as malignant using our proposed CLE and ROSE 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 and ROSE interpretation criteria divided by the total number of benign lesions. The positive predictive value is the percentage of true malignant lesions among all lesions identified as malignant using our proposed CLE and ROSE interpretation criteria. The negative predictive value is the percentage of true benign lesions among all lesions identified as benign using our proposed CLE and ROSE interpretation criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | 20030 | China |
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| 6 months post-procedure |
| Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of CLE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy | 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. 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. 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 |
| Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of ROSE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy | Accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed ROSE interpretation criteria divided by the total number of lesions. Sensitivity is defined as the number of lesions correctly identified as malignant using our proposed ROSE 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 ROSE interpretation criteria divided by the total number of benign lesions. The positive predictive value is the percentage of true malignant lesions among all lesions identified as malignant using our proposed ROSE interpretation criteria. The negative predictive value is the percentage of true benign lesions among all lesions identified as benign using our proposed ROSE interpretation criteria. | 6 months post-procedure |
| Diagnosis accuracy of CLE combined with ROSE in differential diagnosis of different types of intrathoracic lymphadenopathy | Different types of common malignant intrathoracic lymphadenopathy include pulmonary adenocarcinoma, squamous cell lung carcinoma, small cell lung carcinoma and so on. Different types of common benign intrathoracic lymphadenopathy include tuberculosis, sarcoidosis, fungal infection and so on. | 6 months post-procedure |
| Diagnosis accuracy of CLE or ROSE alone in differential diagnosis of different types of intrathoracic lymphadenopathy | Different types of common malignant intrathoracic lymphadenopathy include pulmonary adenocarcinoma, squamous cell lung carcinoma, small cell lung carcinoma and so on. Different types of common benign intrathoracic lymphadenopathy include tuberculosis, sarcoidosis, fungal infection and so on. | 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 |