Low-dose versus standard-dose computed tomography-guided biopsy for pulmonary nodules: a randomized controlled trial

Abstract

Background: To assess relative safety and diagnostic performance of low- and standard-dose computed tomography (CT)-guided biopsy for pulmonary nodules (PNs). Materials and methods: This was a single-center prospective randomized controlled trial (RCT). From June 2020 to December 2020, consecutive patients with PNs were randomly assigned into low- or standard-dose groups. The primary outcome was diagnosis accuracy. The secondary outcomes included technical success, diagnostic yield, operation time, radiation dose, and biopsy-related complications. This RCT was registered on 3 January 2020 and listed within ClinicalTrials.gov (NCT04217655). Results: Two hundred patients were randomly assigned to low-dose (n = 100) and standard-dose (n = 100) groups. All patients achieved the technical success of CT-guided biopsy and definite final diagnoses. No significant difference was found in operation time (n = 0.231) between the two groups. The mean dose-length product was markedly reduced within the low-dose group compared to the standard-dose group (31.5 vs. 333.5 mGy-cm, P < 0.001). The diagnostic yield, sensitivity, specificity, and accuracy of the low-dose group were 68%, 91.5%, 100%, and 94%, respectively. The diagnostic yield, sensitivity, specificity, and accuracy were 65%, 88.6%, 100%, and 92% in the standard-dose group. There was no significant difference observed in diagnostic yield (P = 0.653), diagnostic accuracy (P = 0.579), rates of pneumothorax (P = 0.836), and lung hemorrhage (P = 0.744) between the two groups. Conclusions: Compared with standard-dose CT-guided biopsy for PNs, low-dose CT can significantly reduce the radiation dose, while yielding comparable safety and diagnostic accuracy.