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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
49
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)
Hopital Erasme
Brussels, Belgium
Diagnostic yield
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
Time frame: Through study completion, an average of 1 year
Rate of pneumothorax
On the basis of control chest Xray performs after the endoscopic intervention. The need of chest drainage will also be recorded.
Time frame: up to 1 month after the procedure
Rate of bleeding
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.
Time frame: up to 1 month after the procedure
Duration of the interventions
The total duration of the bronchoscope intervention will be recorded.
Time frame: Up to one day after the procedure
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