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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopy suite | Active Comparator | In this arm, ENB procedure will be performed in a classical endoscopy suite equipped by a fluoroscopy. |
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| CBCT suite | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy | Procedure | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Bondue, PhD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Erasme | Brussels | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37245012 | Derived | Bondue B, Taton O, Tannouri F, Van de Velde N, Remmelink M, Leduc D. High diagnostic yield of electromagnetic navigation bronchoscopy performed under cone beam CT guidance: results of a randomized Belgian monocentric study. BMC Pulm Med. 2023 May 27;23(1):185. doi: 10.1186/s12890-023-02492-7. |
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When published, the datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
After the publication of the results
The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
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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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
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