Peripheral Pulmonary Nodules
Conditions
Keywords
electromagnetic navigation bronchoscopy(ENB), peripheral pulmonary nodules, diagnostic yield
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.
Interventions
ENB is carried out by a ENB system（LungCare, China) with/without other guided bronchoscopy techniques and/or ROSE, which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
Sponsors
Air Force Military Medical University, China
Xiangya Hospital of Central South University
Shanghai Chest Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are older than 18 year-old. 2. 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. 3. Patients who agree to undergo bronchoscopy without any contraindications. 4. Patients who have good compliance and sign informed consent.
Exclusion criteria
1. Presence of concomitant endobronchial lesion during the brochoscopy procerdure. 2. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 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
| Measure | Time frame | Description |
|---|---|---|
| The difference of diagnostic yield among groups of different methods of using ENB | One year | ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well.The difference of diagnostic yield among groups of different methods of using ENB will be analyzed. |
| Factors affecting diagnostic yield | One year | Factors affecting diagnostic yield including lesion size,bronchus sign, location and so on will be analyzed. |
| The difference of diagnostic yield among groups using different locatable guides | One year | There are three kinds of locatable guides with different outer diameters. The difference of diagnostic yield among groups using different locatable guides will be analyzed. |
| Operation time | One year | Operation time includes total operation time,total GS time and total EBUS time. |
| Incidence of complications | One year | Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation. |
Countries
China
Outcome results
None listed