European radiology · 2019
Computed tomography-guided lung biopsy: a randomized controlled trial of low-dose versus standard-dose protocol.
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Fu Yu-Fei, Li Guang-Chao, Xu Qing-Song, Shi Yi-Bing, Wang Chen, Wang Tao
Аннотация
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.
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.