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

Free University of Brussels (ULB)

Status: Completed

Conditions: Pulmonary Disease; Lung Cancer

Treatments: Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05257382

P2019/617

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Endoscopy suite

Active Comparator group

Description:

In this arm, ENB procedure will be performed in a classical endoscopy suite equipped by a fluoroscopy.

Treatment:

Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy

CBCT suite

Experimental group

Description:

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.

Treatment:

Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy