early stage lung cancer peripheral pulmonary nodules
Conditions
Interventions
Not applicable, this is a diagnostic study investigating a new combination of
currently commercially available techniques. See the research protocol for more
details.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 or analogs, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first objective is to exploratively study diagnostic yield and navigational accuracy of the studied combination of imaging and navigational modalities. For studying navigational accuracy we will evaluate if the combination of the studied modalities is able to navigate to the peripheral lung lesion in all cases. If not and/or an unrepresentative diagnosis is found, an exploratory analysis will be performed to correlate lesion characteristics to study procedure performance. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to study safety and cost-effectiveness of the diagnostic procedures. To be able to analyse cost-effectiveness and workflow integration of the combined modalities, the study procedures will be compared against the conventional diagnostic TBB work-up (rEBUS and fluoroscopy guided followed by CT guided TTNA and prevented surgical biopsies) by historic database research. Comparison is performed by mathematically modelling the study procedures and the conventional work-up. For doing so, multiple parameters will be recorded in a quantitative way (also see the study protocol). In case of partially missing data in these continuous variables, missing data will be extrapolated from other recorded procedures. Standard deviations and means will be used for developing a mathematical cost-effectiveness model. The conventional procedure cost-effectiveness will be extrapolated from Radboudumc database and reported literature research. | — |
Countries
Netherlands
Outcome results
None listed