Optical Biopsy and Cytological Evaluation for Intrathoracic Lymphadenopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CLE and ROSE.
- Who it may be relevant to
- Registry conditions: Intrathoracic Lymphadenopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Confocal Laser Endomicroscopy Combined With Rapid On-Site Cytological Evaluation for the Diagnosis of Intrathoracic Lymphadenopathy
Overview
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.
Interventions
- Diagnostic test CLE and ROSE
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.
Primary outcome measures
- Diagnostic accuracy of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy [Time frame: 6 month post-procedure]
Secondary outcome measures (6)
- Sensitivity, specificity, positive predictive value and negative predictive value of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy [Time frame: 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 [Time frame: 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 [Time frame: 6 months post-procedure]
- Diagnosis accuracy of CLE combined with ROSE in differential diagnosis of different types of intrathoracic lymphadenopathy [Time frame: 6 months post-procedure]
- Diagnosis accuracy of CLE or ROSE alone in differential diagnosis of different types of intrathoracic lymphadenopathy [Time frame: 6 months post-procedure]
- Incidence of complications [Time frame: 1 month post-procedure]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Shanghai Chest Hospital — Shanghai
Identifiers
NCT: NCT07047417 · KS25034