Pulmonary Nodule, Solitary
Conditions
Brief summary
Since the beginning of lung screening program in the different countries around the world by chest CT scan, numerous lung nodules and masses of unknown etiology are diagnosed. Usually, the pathological diagnosis is obtained by bronchoscopy. However, peripheral bronchi cannot be seen after the fifth bronchial division as the diameter of the broncoscope is greated than the diameter of the bronchi. Therefore, the Iriscope was developed. It consists in a thin catheter with a mini-camera at its distal extremity. The aime of this study is to evaluate the diagnostic yield of bronchoscopy guided by Iriscope in the setting of peripheral lung nodules and masses supect of malignancy, to compare the Iriscope to endobronchial radial ultrasonography (which is a validated technique to guide bronchoscopy in the setting of peripheral lung nodules and masses) and to evaluate the added value on the diagnostic yield by combining these 2 techniques.
Interventions
DEVICEIriscope
The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lung nodules or masses suspect of malignancy with a diameter between 2 and 5 centimeters
Exclusion criteria
* Any contraindication to general anesthesia * Coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield of bronchoscopy | Pathological diagnosis just after the bronchoscopy. In case of unspecified diagnosis after bronchoscopy, a follow up may be performed by chest ct scan up to 6 months. | The diagnosis will be obtained by pathological analysis. The diagnostic yield is the number of cases with a pathological diagnosis obtained by bronchoscopy on the total number of cases. In case of unspecified diagnosis, the fianal diagnosis will be given by the pathological naalysis of the surgical resection or chest CT follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications of bronchoscopy | Just after the bronchoscopy to 1 month after the procedure | Number of participants that present a pneumothorax or hemorrhage after the bronchoscopy |
Countries
Belgium
Outcome results
None listed