Yu-Fei Fu1, Guang-Chao Li1, Qing-Song Xu1, Yi-Bing Shi1, Chen Wang1, Tao Wang2. 1. Department of Radiology, Xuzhou Central Hospital, 199 South Jiefang Road, Xuzhou, 221009, China. 2. Department of Radiology, Xuzhou Central Hospital, 199 South Jiefang Road, Xuzhou, 221009, China. wangtao2019@yeah.net.
Abstract
OBJECTIVES: To assess the relative diagnostic utility of low- and standard-dose computed tomography (CT)-guided lung biopsy. METHODS: In this single-center, single-blind, prospective, randomized controlled trial, patients were enrolled between November 2016 and June 2017. Enrolled study participants were randomly selected to undergo either low- or standard-dose CT-guided lung biopsy. Diagnostic accuracy was the primary study endpoint, whereas technical success, radiation dose, and associated complications were secondary study endpoints. RESULTS: In total, 280 patients underwent study enrollment and randomization, with 271 (low-dose group, 135; standard-dose group, 136) receiving the assigned interventions. Both groups had a 100% technical success rate for CT-guided lung biopsy, and complication rates were similar between groups (p > 0.05). The mean dose-length product (36.0 ± 14.1 mGy cm vs. 361.8 ± 108.0 mGy cm, p < 0.001) and effective dose (0.5 ± 0.2 mSv vs. 5.1 ± 1.5 mSv, p < 0.001) were significantly reduced in the low-dose group participants. Sensitivity, specificity, and overall diagnostic accuracy rates in the low-dose group were 91.8%, 100%, and 94.6%, respectively, whereas in the standard-dose group, the corresponding values were 89.6%, 100%, and 92.4%, respectively. These results indicated that diagnostic performance did not differ significantly between the 2 groups. Using univariate and multivariate analyses, we found larger lesion size (p = 0.038) and procedure-related pneumothorax (p = 0.033) to both be independent predictors of diagnostic failure. CONCLUSIONS: Our results demonstrate that low-dose CT-guided lung biopsy can yield comparable diagnostic accuracy to standard-dose CT guidance, while significantly reducing the radiation dose delivered to patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02971176 KEY POINTS: • Low-dose CT-guided lung biopsy is a safe and simple method for diagnosis of lung lesions. • Low-dose CT-guided lung biopsy can yield comparable diagnostic accuracy to standard-dose CT guidance. • Low-dose CT-guided lung biopsy can achieve a 90% reduction in radiation exposure when compared with standard-dose CT guidance.
RCT Entities:
OBJECTIVES: To assess the relative diagnostic utility of low- and standard-dose computed tomography (CT)-guided lung biopsy. METHODS: In this single-center, single-blind, prospective, randomized controlled trial, patients were enrolled between November 2016 and June 2017. Enrolled study participants were randomly selected to undergo either low- or standard-dose CT-guided lung biopsy. Diagnostic accuracy was the primary study endpoint, whereas technical success, radiation dose, and associated complications were secondary study endpoints. RESULTS: In total, 280 patients underwent study enrollment and randomization, with 271 (low-dose group, 135; standard-dose group, 136) receiving the assigned interventions. Both groups had a 100% technical success rate for CT-guided lung biopsy, and complication rates were similar between groups (p > 0.05). The mean dose-length product (36.0 ± 14.1 mGy cm vs. 361.8 ± 108.0 mGy cm, p < 0.001) and effective dose (0.5 ± 0.2 mSv vs. 5.1 ± 1.5 mSv, p < 0.001) were significantly reduced in the low-dose group participants. Sensitivity, specificity, and overall diagnostic accuracy rates in the low-dose group were 91.8%, 100%, and 94.6%, respectively, whereas in the standard-dose group, the corresponding values were 89.6%, 100%, and 92.4%, respectively. These results indicated that diagnostic performance did not differ significantly between the 2 groups. Using univariate and multivariate analyses, we found larger lesion size (p = 0.038) and procedure-related pneumothorax (p = 0.033) to both be independent predictors of diagnostic failure. CONCLUSIONS: Our results demonstrate that low-dose CT-guided lung biopsy can yield comparable diagnostic accuracy to standard-dose CT guidance, while significantly reducing the radiation dose delivered to patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02971176 KEY POINTS: • Low-dose CT-guided lung biopsy is a safe and simple method for diagnosis of lung lesions. • Low-dose CT-guided lung biopsy can yield comparable diagnostic accuracy to standard-dose CT guidance. • Low-dose CT-guided lung biopsy can achieve a 90% reduction in radiation exposure when compared with standard-dose CT guidance.