Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Study Evaluating the Added Value of an Hybrid Room Equipped With a Cone Beam CT (CBCT) to Electromagnetic Navigation Bronchoscopy (ENB) for the Diagnosis of Pulmonary Nodule.

Conditions
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Lung Cancer, Pulmonary Disease

Intervention / Treatment
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* Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria are a higher risk of bleeding (platelets count lower than 80,000/mm³, a systolic pulmonary arterial pressure (sPAP) higher than 45 mmHg at transthoracic ultrasonography, prothrombin time international normalized ratio - INR >1.5, activated partial thromboplastin time - APTT >35, uninterrupted anti-coagulant/anti-aggregant therapy), and the presence of any contraindication to general anesthesia as determined by the principal investigator (significant cardiac comorbidities, hypercapnia, severe hypoxia...). No strict limits for inclusion were applied regarding diffusing capacity for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in 1 second (FEV1).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopy suite<br>In this arm, ENB procedure will be performed in a classical endoscopy suite equipped by a fluoroscopy. | Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy<br>* 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)<br>|
| Experimental: CBCT suite<br>In this arm, ENB procedure will be performed in a n hybrid room equipped by a cone beam CT (CBCT). This will allow to perform a real time visualisation of the lesion, enhanced fluoroscopy and to use the CrossCountry technique if required. | Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of pneumothorax | On the basis of control chest Xray performs after the endoscopic intervention. The need of chest drainage will also be recorded. | 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. | up to 1 month after the procedure | 
| Duration of the interventions | The total duration of the bronchoscope intervention will be recorded. | Up to one day after the procedure |