A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
Study Overview
Brief Summary
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •Pregnant or lactating women；
- •Patients with contraindications to bronchoscopy；
- •Patients with other conditions that, in the opinion of the investigator, make the patient unsuitable for the study.
Arms & Interventions
Contrast-Enhanced Endobronchial Ultrasound
Intervention: Contrast-enhanced endobronchial ultrasound (Device)
Outcomes
Primary Outcomes
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
Time Frame: 6 month post-procedure
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.
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions
Time Frame: 6 month post-procedure
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.
Secondary Outcomes
- Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy(6 months post-procedure)
- Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions(6 months post-procedure)
Investigators
Jiayuan Sun
Vice-President of the hospital
Shanghai Chest Hospital