Lung Cancer, Pulmonary Disease
Conditions
Brief summary
A monocentric prospective and randomized trial aiming to compare the diagnostic yield and safety of electromagnetical-guided bronchoscopy (ENB) procedures coupled to trans-bronchial lung cryobiopsies for the diagnosis of pulmonary nodule when performed either in a standard bronchoscopy suite or in a hybrid room with CBCT guidance and the use of the CrossCountry technique as required.
Interventions
PROCEDUREENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy
After having performed the ENB procedure to reach the identified lung lesion, biopsies will be performed (six forceps trans-bronchial biopsies and one trans-bronchial lung cryobiopsy)
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
* Pulmonary nodule of maximum 30mm of largest diameter * Nodules can be either solid or subsolid (including GGO) without evidence of loco-regional or distant metastasis that could be biopsied, and no evidence for an infectious underlying disease. * A multidisciplinary discussion is performed for each case before considering its inclusion in the study in order to validate the indication of ENB-guided biopsy. Of note, any other endoscopic or trans-thoracic procedure should be tried before considering ENB if it could achieve the diagnosis according to the investigator's judgment.
Exclusion criteria
* Patient eligible for a direct surgical resection of the nodule * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Through study completion, an average of 1 year | The primary outcome will be the comparison of the diagnostic yield obtained when ENB procedures will be performed on either the classical endoscopic suite or in the CBCT suite |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bleeding | up to 1 month after the procedure | Bleeding will be scored as follows: score 0, when no bleeding occurs; score 1, when bleeding stops within five minutes either spontaneously or by inflation of a Fogarty balloon; score 2, when bleeding is prolonged more than five minutes or needs cold saline instillation; and score 3, when bleeding requires embolization, selective bronchial intubation, transfusion, admission in the intensive care unit, results in prolonged hospital stay, or patient's death. |
| Rate of pneumothorax | up to 1 month after the procedure | On the basis of control chest Xray performs after the endoscopic intervention. The need of chest drainage will also be recorded. |
| Duration of the interventions | Up to one day after the procedure | The total duration of the bronchoscope intervention will be recorded. |
Countries
Belgium
Outcome results
None listed