Endpoints
malignancy, TN/(TN, true-positives
SECONDARY
The primary endpoint was the comparison of the diagnostic yield and the diagnostic accuracy obtained in the two arms of the study (endoscopy suite vs CBCT suite). The diagnostic yield was defined as the proportion of patients of each group with a definite pathological diagnosis (malignant or non-malignant) following the ENB procedure compared to the corresponding total number of patients. Of note, patients without diagnosis after the ENB and a minimum follow up of 12 months were not excluded from the determination of the diagnostic yield. The diagnostic accuracy was calculated as the rate of true-positives (for malignancy) (TP) plus true-negatives (for malignancy) (TN) of all subjects with attempted lung lesion biopsies. Patients with a lost to follow up were excluded from the determination of the diagnostic accuracy. However, these cases were further included in a sensitivity analysis, assuming all were FN and then TN, to provide low and high estimates of the diagnostic accuracy.Secondary endpoints included sensitivity defined as the proportion of positives that are correctly identified as such (TP/TP + FN), specificity defined as the proportion of negatives that are correctly identified as such (TN/TN + FP), positive predictive value defined as TP/(TP + FP), and negative predictive value defined as TN/(TN + FN). We determined also in each group the rate of adequate location of the endoscopic tool within the targeted lesion (“lesion reached”) defined by the combination of the presence of abnormal lung parenchyma (with or without a clear pathological diagnosis), and a confirmation of the adequate localization of the biopsy tool within the nodule on the basis of the result of r-EBUS, CBCT or fluoroscopy acquisition. Other secondary endpoints include safety data, duration of procedures, diagnostic yields of forceps TBB and cryobiopsy (globally and in each arm separately).