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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iriscope | Experimental |
| |
| EBUS | Active Comparator |
| |
| Combined Iriscope + EBUS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iriscope | Device | The use of Iriscope to improve the diagnostic yield of bronchoscopy in the setting of peripheral lung nodules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield of bronchoscopy | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of bronchoscopy | Number of participants that present a pneumothorax or hemorrhage after the bronchoscopy | Just after the bronchoscopy to 1 month after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Taton, Resident | Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Brussels | 1070 | Belgium |
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| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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