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

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Chen reporting having a related patent pending at the US Patent and Trademark Office (EFS ID, 30041066). No other disclosures were reported.

Figures

Figure 1.. Workflow of Template-Guided Lung Nodule Localization

Preevaluation of localization deviation prior to needle insertion consists of evaluating an imaginary line drawn from the puncture point toward the target nodule. CT indicates computed tomography.

Figure 2.. Flowchart of the Study Participants

CT indicates computed tomography.

Figure 3.. Localizer Deviation Between the Computed Tomography (CT)– and Template-Guided Groups in 3 Dimensions (3-D)

A, Comparison of the localizer deviation in each dimension. The horizontal line in each box indicates the median, while the top and bottom borders of each box indicate the 75th and 25th percentiles, respectively. The ends of the whiskers above and below each box indicate the minimum and maximum values. The points beyond the whiskers indicate outliers that are beyond the quartiles by 1.5 interquartiles. B, Comparison of the 3-dimensional deviation. Negative values for anterior-posterior, coronal, or vertical deviations indicate that the localizer deviates posteriorly, laterally, or caudally, respectively.