Percutaneous needle biopsy of lung nodules under CT fluoroscopic guidance with use of the “I-I device”

Abstract

The aim of this study is to evaluate the feasibility and safety of CT fluoroscopic-guided needle biopsy with the use of the “I-I device”, which was developed to assist in precisely advancing the needle while avoiding irradiation to the operator's hand. Using the “I-I device” under CT fluoroscopic guidance, 131 percutaneous needle lung biopsies were performed followed by histopathological evaluation. The final diagnosis was confirmed by independent surgical pathological findings or clinical follow-up. The rate of success in obtaining specimens adequate for histopathological analysis was 100% (131/131). For the 104 lesions that we were able to follow up, sensitivity, specificity and accuracy in diagnosing malignancy were 93.8%, 100% and 95.2%, respectively. In 51 lesions for which surgery was performed, the specific cell type was characterized in 98.0% (50/51; malignant, n = 38; benign, n = 12). The specific cell type was precisely diagnosed and confirmed after surgery in 36 malignant lesions and 8 benign lesions. Biopsy-induced complications were pneumothorax in 34.0% (44/131) and haemoptysis in 9.9% (13/131). None of the patients had serious complications. In conclusion, CT fluoroscopic-guided lung biopsy with use of the “I-I device” provides a high degree of diagnostic accuracy, allows specific characterization of lung nodules and can be performed safely.