Optical Biopsy and Cytological Evaluation for Intrathoracic Lymphadenopathy
- Conditions
- Intrathoracic Lymphadenopathy
- Registration Number
- NCT07047417
- Lead Sponsor
- Shanghai Chest Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Age >18 years old.
- Chest CT shows at least one enlarged intrathoracic lymph node (short axis >1 cm), or PET / CT shows increased fluorodeoxyglucose uptake (standard uptake value > 2.5) in at least one intrathoracic lymph node.
- CP-EBUS-TBNA is required to determine the diagnosis or staging.
- Patients who have good compliance and sign informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy 6 month post-procedure 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.
- Secondary Outcome Measures
Name Time Method Diagnosis accuracy of CLE combined with ROSE in differential diagnosis of different types of intrathoracic lymphadenopathy 6 months post-procedure 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.
Diagnosis accuracy of CLE or ROSE alone in differential diagnosis of different types of intrathoracic lymphadenopathy 6 months post-procedure 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.
Sensitivity, specificity, positive predictive value and negative predictive value of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy 6 months post-procedure 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.
Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of CLE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy 6 months post-procedure 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.
Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of ROSE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy 6 months post-procedure 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.
Incidence of complications 1 month post-procedure Complications mean a composite of procedure related adverse advents during and after the operation
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Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Chest Hospital🇨🇳Shanghai, Shanghai, ChinaJiayuan SunContact+86-021-22200000jysun1976@163.com