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

Not Applicable

Completed

• Conditions: Lung Cancer; Pulmonary Disease
• Interventions: Procedure: ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy

• Registration Number: NCT05257382
• Lead Sponsor: Erasme University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBCT suite	ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy	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.
Endoscopy suite	ENB followed by trans-bronchial biopsy and trans-bronchial cryobiopsy	In this arm, ENB procedure will be performed in a classical endoscopy suite equipped by a fluoroscopy.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	Through study completion, an average of 1 year	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

Secondary Outcome Measures

Name	Time	Method
Duration of the interventions	Up to one day after the procedure	The total duration of the bronchoscope intervention will be recorded.
Rate of pneumothorax	up to 1 month after the procedure	On the basis of control chest Xray performs after the endoscopic intervention. The need of chest drainage will also be recorded.
Rate of bleeding	up to 1 month after the procedure	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.

Trial Locations

Locations (1)

Hopital Erasme; 🇧🇪 Brussels, Belgium