Lei Zhang1, Long Wang1, Xiermaimaiti Kadeer2, Li Zeyao1, Xiwen Sun3, Weiyan Sun1, Yunlang She1, Dong Xie1, Mu Li4, Liling Zou5,6, Gaetano Rocco7, Ping Yang8, Chang Chen1, Chia-Chuan Liu9, René H Petersen10, Calvin Sze Hang Ng11, Scott Parrish12, Yu Shrike Zhang13, Raffaele Giordano14, Luigi di Tommaso14. 1. Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China. 2. Department of Thoracic Surgery, The Sixth People's Hospital of Nantong, Jiang Su, People's Republic of China. 3. Department of Radiology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China. 4. Department of Medicine, Saint Vincent Hospital, Worcester, Massachusetts. 5. Department of Medical Statistics, Tongji University School of Medicine, Shanghai, People's Republic of China. 6. Clinical and Translational Science Institute, University of Rochester Medical Center, Rochester, New York. 7. Department of Thoracic Diseases, National Cancer Institute, Pascale Foundation, Naples, Italy. 8. Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. 9. Division of Thoracic Surgery, Department of Surgery, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan. 10. Department of Cardiothoracic Surgery, Rigshospitalet, Copenhagen, Denmark. 11. Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Town, Hong Kong. 12. Fox Valley Pulmonary Medicine, Appleton, Wisconsin. 13. Division of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. 14. Department of Advanced Biomedical Sciences, Adult and Pediatric Cardiac Surgery, University of Naples Federico II, Naples, Italy.
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 eitherCT- 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.
RCT Entities:
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.