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Original Investigation
December 26, 2018

Accuracy of a 3-Dimensionally Printed Navigational Template for Localizing Small Pulmonary Nodules: A Noninferiority Randomized Clinical Trial

Author Affiliations
  • 1Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China
  • 2Department of Thoracic Surgery, The Sixth People’s Hospital of Nantong, Jiang Su, People’s Republic of China
  • 3Department of Radiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China
  • 4Department of Medicine, Saint Vincent Hospital, Worcester, Massachusetts
  • 5Department of Medical Statistics, Tongji University School of Medicine, Shanghai, People’s Republic of China
  • 6Clinical and Translational Science Institute, University of Rochester Medical Center, Rochester, New York
  • 7Department of Thoracic Diseases, National Cancer Institute, Pascale Foundation, Naples, Italy
  • 8Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
  • 9Division of Thoracic Surgery, Department of Surgery, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan
  • 10Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen, Denmark
  • 11Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Town, Hong Kong
  • 12Fox Valley Pulmonary Medicine, Appleton, Wisconsin
  • 13Division of Engineering in Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 14Department of Advanced Biomedical Sciences, Adult and Pediatric Cardiac Surgery, University of Naples Federico II, Naples, Italy
JAMA Surg. Published online December 26, 2018. doi:10.1001/jamasurg.2018.4872
Key Points

Question  Are the safety and efficacy of a 3-dimensionally printed navigational template guide for localizing small percutaneous lung nodules noninferior to the conventional computed tomography–guided method?

Findings  In this single-center, noninferiority randomized clinical trial of 190 patients, lung nodule localization accuracy using the template-guided approach was noninferior to that using the conventional method. Compared with the conventional approach, the template-guided procedure was significantly faster and significantly decreased patient radiation exposure.

Meaning  The accuracy of the template-guided lung nodule localization appears noninferior to and this method appears safer than the computed tomography–guided method; thus, this new approach may provide patients with an option for undergoing lung nodule localization without computed tomographic scan dependency.


Importance  Localization of small lung nodules are challenging because of the difficulty of nodule recognition during video-assisted thoracoscopic surgery. Using 3-dimensional (3-D) printing technology, a navigational template was recently created to assist percutaneous lung nodule localization; however, the efficacy and safety of this template have not yet been evaluated.

Objective  To assess the noninferiority of the efficacy and safety of a 3-D–printed navigational template guide for localizing small peripheral lung nodules.

Design, Setting, and Participants  This noninferiority randomized clinical trial conducted between October 2016 and October 2017 at Shanghai Pulmonary Hospital, Shanghai, China, compared the safety and precision of lung nodule localization using a template-guided approach vs the conventional computed tomography (CT)-guided approach. In total, 213 surgical candidates with small peripheral lung nodules (<2 cm) were recruited to undergo either CT- or template-guided lung nodule localization. An intention-to-treat analysis was conducted.

Interventions  Percutaneous lung nodule localization.

Main Outcomes and Measures  The primary outcome was the accuracy of lung nodule localization (localizer deviation), and secondary outcomes were procedural duration, radiation dosage, and complication rate.

Results  Of the 200 patients randomized at a ratio of 1:1 to the template- and CT-guided groups, most were women (147 vs 53), body mass index ranged from 15.4 to 37.3, the mean (SD) nodule size was 9.7 (2.9) mm, and the mean distance between the outer edge of target nodule and the pleura was 7.8 (range, 0.0-43.9) mm. In total, 190 patients underwent either CT- or template-guided lung nodule localization and subsequent surgery. Among these patients, localizer deviation did not significantly differ between the template- and CT-guided groups (mean [SD], 8.7 [6.9] vs 9.6 [5.8] mm; P = .36). The mean (SD) procedural durations were 7.4 (3.2) minutes for the template-guided group and 9.5 (3.6) minutes for the CT-guided group (P < .001). The mean (SD) radiation dose was 229 (65) mGy × cm in the template-guided group and 313 (84) mGy × cm in CT-guided group (P < .001).

Conclusions and Relevance  The use of the 3-D–printed navigational template for localization of small peripheral lung nodules showed efficacy and safety that were not substantially worse than those for the CT-guided approach while significantly simplifying the localization procedure and decreasing patient radiation exposure.

Trial Registration  ClinicalTrials.gov identifier: NCT02952261

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