CT-controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Augmented Fluoroscopy Bronchoscopic Navigation Based Diagnostic Yield

In this exploratory adaptive clinical trial the investigators will examine the diagnostic yield of a combination of commercially available imaging and navigation techniques for reaching peripheral lung lesions. The two investigated techniques will herein be the rEBUS imaging modality combined with augmented fluoroscopy based virtual bronchoscopy navigation. Confirmation of reaching the lung lesion will be by means of CT (fluoroscopic) imaging. Rapid On-Site Evaluation (ROSE) of cytopathology will be used for obtaing a per-procedural outcome on tissue biopsy representativeness. The study will replace the current conventional standard TBB procedure (fluoroscopy and rEBUS guided bronchoscopy) in the endoscopy suite. Consecutive patients will be included on the MITeC hybrid operating room (needed to monitor patient safety and CT availability). All data will be prospectively collected. In case tissue biopsy is found to be malignant or benign, it will be termed representative. In case tissue biopsy is found to be non-representative (=blood, anatomical lung tissue, unreachable), conventional follow-up of CT guided TTNA, follow-up monitoring and/or surgical biopsy will serve as golden standard for obtaining tissue diagnosis. For verification of reaching the target lesion, another study parameter of interest, (cb)CT imaging will be performed for verification that instruments are within the nodule (per-procedurally available).

Sex

All

Minimum age

18 Years

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* ASA physical status 1-3.
* Age 18 years or older.
* A pulmonary lesion (i.e. a focal, rounded opacity mostly surrounded by aerated lung or a ground glass opacity or part- or sub-solid lesion) with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Bleeding disorders.
* Less than 18 years old.
* Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines, clopidrogel, analogs, or, NOAC's).
* Known allergy for lidocaine.
* Uncontrolled pulmonary hypertension.
* Recent and/or uncontrolled cardiac disease.
* Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe).
* ASA classification greater than or equal to 4 (unfit for performing non-surgical biopsy).
* Pregnancy.
* Inability to consent.