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Computed tomography–guided lung biopsy: a randomized controlled trial of low-dose versus standard-dose protocol

  • Yu-Fei Fu
  • Guang-Chao Li
  • Qing-Song Xu
  • Yi-Bing Shi
  • Chen Wang
  • Tao WangEmail author
Interventional
  • 11 Downloads

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.

Keywords

Lung Biopsy Radiation dosage 

Abbreviations

BMI

Body mass index

CI

Confidence interval

CT

Computed tomography

DLP

Dose-length product

ITT

Intention-to-treat

PET

Positron emission tomography

PP

Per-protocol

RCT

Randomized controlled trial

Notes

Funding information

The authors state that this work has not received any funding.

Compliance with ethical standards

Guarantor

The scientific guarantor of this publication is Qing-Song Xu.

Conflict of interest

The authors declare that they have no conflict of interest.

Statistics and biometry

No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was obtained from all patients in this study.

Ethical approval

Institutional Review Board approval was obtained.

Methodology

• prospective

• randomized controlled trial

• performed at one institution

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Copyright information

© European Society of Radiology 2019

Authors and Affiliations

  1. 1.Department of RadiologyXuzhou Central HospitalXuzhouChina

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