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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Lung Lesions
Mediastinal and Hilar Lymph Node Enlargement

Treatments

Device: Contrast-enhanced endobronchial ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT07060378
KS25026

Details and patient eligibility

About

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

Enrollment

250 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

250 participants in 1 patient group

Contrast-Enhanced Endobronchial Ultrasound
Experimental group
Treatment:
Device: Contrast-enhanced endobronchial ultrasound

Trial contacts and locations

1

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Central trial contact

Jiayuan sun

Data sourced from clinicaltrials.gov

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