Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Pulmonary Nodules
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
- Last Updated
- 7 years ago
Overview
Brief Summary
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.
Detailed Description
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.
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) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy.
- •Patients who agree to undergo bronchoscopy without any contraindications.
- •Patients who have good compliance and sign informed consent.
Exclusion Criteria
- •Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- •Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Outcomes
Primary Outcomes
The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
Time Frame: one year
Diagnostic yield is defined as proportion of true positive and true negative.
Secondary Outcomes
- The difference of operation time between ENB-EBUS-GS group and EBUS-GS group(one week)
- The difference of complications between ENB-EBUS-GS group and EBUS-GS group(three months)