Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Pulmonary Nodules
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 479
- Locations
- 1
- Primary Endpoint
- Diagnostic yield
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study is designed as a multi-center prospective trial of ENB for the diagnosis of peripheral pulmonary nodules in the real world. The purpose of the study is to identify the optimal method of using ENB.
Detailed Description
The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.
Investigators
Jiayuan Sun
Director, Department of Endoscopy
Shanghai Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients who are older than 18 year-old.
- •Chest CT shows peripheral pulmonary nodule (8mm\<longest diameter≤30mm) suspicious for malignant that needs to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible with standard bronchoscopy.
- •Patients who agree to undergo bronchoscopy without any contraindications.
- •Patients who have good compliance and sign informed consent.
Exclusion Criteria
- •Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Outcomes
Primary Outcomes
Diagnostic yield
Time Frame: One year
Diagnostic yield is defined as proportion of true positive and true negative. The primary endpoint is diagnostic yield of ENB with/without other guided bronchoscopy techniques or ROSE.
Secondary Outcomes
- The difference of diagnostic yield among groups of different methods of using ENB(One year)
- Incidence of complications(One year)
- Factors affecting diagnostic yield(One year)
- The difference of diagnostic yield among groups using different locatable guides(One year)
- Operation time(One year)