Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following:

• Malignant, OR

• Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR

• Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND

• Absence of malignancy (true negative) through 1-year CT follow-up, defined as:

  • The nodule markedly regresses or resolves on follow-up imaging, OR
  • A persistent nodule has not been diagnosed as malignant, AND
  • No plans for repeat invasive diagnostic procedures through 12 months follow-up.

Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.

Our protocol excluded those missing primary outcome data from the primary outcome analysis. The primary outcome was adjudicated as 12 months and five patients were lost to follow-up (2 in NB group, 3 in CT-guided Biopsy group). These represent the difference in these denominators for this analysis compared to overall patient numbers. The overall patient numbers (121 an 113) were used as base denominators for all other outcomes.

Rate at which histopathology is obtained which explains the presence of a nodule (according to definitions set forth for the primary endpoint) and permits post-biopsy clinical decision-making without need for immediate additional diagnostic procedures.

Proportion of cases complicated by pneumothorax

Proportion of cases complicated by pneumothorax requiring chest tube placement

Proportion of cases with complication necessitating hospitalization after a procedure

Total time required to complete the procedure

Association of diagnostic yield with type of tools used to obtain biopsy: F-Nav Bronchoscopy group. This outcome measure is only applicable to the patients randomized to the navigational bronchoscopy platform.

Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.

Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.

Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

Association of diagnostic yield with presence of a bronchus sign

Each trial arm is being split into two groups, whether a bronchus sign was present or absent. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.

Association of diagnostic yield with biopsy site (nodule location)

Each trial arm is being split into two groups, whether the lung nodule is in the outer-third zone or middle-third zone. This is sub-group analysis for each trial arm hence the different denominators. If you add the denominators for each column, it totals the overall number of participants for that trial arm.

Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed

Proportion of cases in which a subsequent procedure was performed for staging

Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy*cm^2)

The NB arm has units of mGy*cm^2.

Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.

Total number of patients included in this analysis was 119. Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.

The proportion of biopsy procedures yielding a confident clinical diagnosis including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens.

Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy*cm)

CT-guided biopsy arm has units of mGy*cm

Association of diagnostic yield with type of tools used to obtain biopsy: CT-guided group. This outcome measure is only applicable to the patients randomized to the CT-guided procedure.

16 patients not included: CT performed on the day of the procedure demonstrated regressing nodules in 10 patients and the proceduralist decided to cancel in 6 patients. There were pre-specified exclusion criteria for this outcome measure.

Two patients randomized to the bronchoscopy arm did not undergo the procedure because they had lesions that were regressing on the day of the exam. This was a pre-specified exclusion criterion in the statistical analysis plan for this outcome measure.