A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorShanghai Chest Hospital
About this trial
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years old；
Enlargement of at least one intrathoracic LN (short diameter > 1 cm) or central parenchymal lung lesions adjacent to the airway detected on chest CT, or increased fluorodeoxyglucose uptake in at least one intrathoracic lymph node on PET / CT (standardized uptake value > 2.5)；
CP-EBUS-TBNA is required to determine the diagnosis or staging, the patient agreed to undergo CE-EBUS, and there were no contraindications to EBUS-TBNA;
Patients who have good compliance and sign informed consent.
Disqualifiers
Patients with known hypersensitivity to ultrasound contrast components;
Patients with severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg);
Patients with angina pectoris, acute coronary syndrome, clinically unstable ischemic heart disease, heart failure, cardiac dysfunction, and cardiac disease with right-to-left shunting;
Patients with uncontrolled essential hypertension and adults with respiratory distress syndrome;
Trial design
Design model
Single group
Treatments tested in this trial
Contrast-enhanced endobronchial ultrasound
DeviceUsing CE-EBUS to observe pulmonary lesions and abnormal enlarged intrathoracic lymph nodes, the enhancement characteristics of benign and malignant lesions under CE-EBUS were extracted for both conditions.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Contrast-Enhanced Endobronchial UltrasoundExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using CE-EBUS interpretation criteria.
Time frame
6 month post-procedure2
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions
Diagnostic accuracy was defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using the CE-EBUS interpretation criteria.
Time frame
6 month post-procedureSecondary outcomes
1
Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions. Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions. Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria. Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.
Time frame
6 months post-procedure2
Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions
Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions. Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions. Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria. Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.
Time frame
6 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov