Status:
COMPLETED
Added Value of Cone Beam CT Guidance to Electromagnetic Navigation Bronchoscopy for the Diagnosis of Pulmonary Nodule.
Lead Sponsor:
Erasme University Hospital
Conditions:
Lung Cancer
Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05257382
Start Date
February 1 2020
End Date
April 1 2022
Last Update
July 27 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Erasme
Brussels, Belgium, 1070