A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes

Shanghai Chest Hospital250 enrolled

Overview

Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

250

Conditions

Lung Lesions Mediastinal and Hilar Lymph Node Enlargement

Interventions

Contrast-enhanced endobronchial ultrasoundDEVICE

Using 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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-procedure

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-procedure

Secondary Outcomes

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-procedure

Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions

Central Contacts

Jiayuan sun

CONTACT

+1511 86-021-22200000 jysun1976@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.