lung cancer suspicious peripheral pulmonary lesions
Conditions
Interventions
The navigation bronchoscopy procedure consists of three phases: (1) navigation,
(2) confirmation of the correct position and (3) tissue acquisition of the
pulmonary nodule. The navigation and confir
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients with an indication for cone-beam CT guided navigation bronchoscopy for the diagnosis of a peripheral pulmonary nodule are eligible for study inclusion. 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 above 18 years - A single pulmonary nodule with an indication for diagnostic evaluation following current clinical guidelines - Subject is willing and able to give written informed consent for clinical investigation participation prior to the procedure
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Contra-indication for navigation bronchoscopy - Not fit to undergo navigation bronchoscopy - Patient is pregnant - Inability to consent - Less than 18 years old - Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarin, warfarin, therapeutic dose of low molecular weight heparins, clopidogrel or analogs, NOAC*s) - Uncontrolled pulmonary hypertension - Recent and/or uncontrolled cardiac disease - Compromised upper airway (e.g., central airway stenosis for any reason such that endobronchial access is considered unsafe) - Patient is involved in another pulmonary intervention study - Indication for minimal invasive biopsy of multiple nodules in one procedure - Endobronchial visible tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this safety and efficacy study is to assess the overall diagnostic yield. Diagnostic yield is defined as the number of times the procedure was diagnostic (either malignant or benign), relative to the total number of attempted navigation procedures. The criteria for what constitutes a diagnostic sample will be modelled after the strict definitions as proposed by Vachani et al. (Vachani et al. Chest, 2020). When applying this definition, a diagnosis can only be determined based on pathology results from the study procedure and without follow-up information. Diagnostic outcomes are malignant or specific benign diagnoses (e.g., granulomatous inflammation, fungal infection). All other findings are categorized as non-diagnostic. This definition allows for a conservative analysis of the outcomes, and has strong clinical applicability. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to assess safety. The most common complication that can be expected are pneumothorax (with or without requiring chest tube drainage) and bleeding. Bleeding will be classified according to standardized definitions proposed by folch et al. (Folch et al. Chest, 2020) Other secundary outcomes are - Position confirmation of the instrument confirmed by cone-beam CT (CBCT) - Biopsy instrument characteristics, primarily: biopsy duration per sampling strategy and the number of biopsies taken - Ease of use of the research tool - The pathology outcome of tissue samples analyzed during rapid onsite evaluation (ROSE) - Suitability of the obtained tissue for any subsequent full molecular analysis. | — |
Countries
Netherlands
Outcome results
None listed