Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.
NCT ID: NCT05257382
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2020-02-01
2022-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Endoscopy suite
In this arm, ENB procedure will be performed in a classical endoscopy suite equipped by a fluoroscopy.
ENB 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)
CBCT suite
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.
ENB 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)
Interventions
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ENB 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)
Eligibility Criteria
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Inclusion Criteria
* 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
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).
18 Years
ALL
No
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Benjamin Bondue
Chest physician - MD PhD
Principal Investigators
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Benjamin Bondue, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasme University Hospital
Locations
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Hopital Erasme
Brussels, , Belgium
Countries
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References
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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.
Other Identifiers
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P2019/617
Identifier Type: -
Identifier Source: org_study_id
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