Rafael Paez, Robert J Lentz, Jennifer D Duke, Justin K Siemann, Cristina Salmon, Greta J Dahlberg, Ankush Ratwani, Jonathan D Casey, Heidi Chen, Sheau-Chiann Chen, Samira Shojaee, Otis B Rickman, Cheryl L Gatto, Todd W Rice, Fabien Maldonado
{"title":"机器人与电磁支气管镜检查周围肺病变：一项随机试验（RELIANT）。","authors":"Rafael Paez, Robert J Lentz, Jennifer D Duke, Justin K Siemann, Cristina Salmon, Greta J Dahlberg, Ankush Ratwani, Jonathan D Casey, Heidi Chen, Sheau-Chiann Chen, Samira Shojaee, Otis B Rickman, Cheryl L Gatto, Todd W Rice, Fabien Maldonado","doi":"10.1164/rccm.202409-1846OC","DOIUrl":null,"url":null,"abstract":"<p><strong>Rationale: </strong>Robotic assisted bronchoscopy has emerged as an alternative to electromagnetic navigational bronchoscopy for patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. While both platforms are routinely used in clinical practice, comparative effectiveness data are lacking.</p><p><strong>Objective: </strong>To compare the effectiveness of robotic assisted and electromagnetic navigational bronchoscopy for evaluation of peripheral pulmonary lesions.</p><p><strong>Methods: </strong>In an investigator-initiated, single-center, cluster randomized noninferiority trial, we assigned patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion to either robotic assisted or electromagnetic navigational bronchoscopy. The cluster randomization unit was the operating room in which patients were scheduled. The primary outcome was the diagnostic yield of the procedure, defined as the proportion of cases yielding lesional tissue. Secondary and safety outcomes included procedure duration and complications.</p><p><strong>Measurements and main results: </strong>Among the 411 patients included in the modified intention to treat analysis, lesional tissue was obtained in 158 of 203 (77.8%) patients in the robotic assisted group and 157 of 208 (75.5%) patients in the electromagnetic group, p-value for non-inferiority 0.007. The median duration of bronchoscopy was 37 minutes in the robotic assisted group and 32 minutes in the electromagnetic group (difference, 5 minutes; 95% confidence interval 2.0 to 7.7). Pneumothorax occurred in 4 patients in the robotic assisted group and 6 patients in the electromagnetic group.</p><p><strong>Conclusions: </strong>In patients undergoing bronchoscopy for the evaluation of a peripheral pulmonary lesion, the diagnostic yield of robotic assisted bronchoscopy was not inferior to that of electromagnetic navigation bronchoscopy. Clinical trial registration available at www.</p><p><strong>Clinicaltrials: </strong>gov, ID: NCT05705544. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).</p>","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":" ","pages":""},"PeriodicalIF":19.4000,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT).\",\"authors\":\"Rafael Paez, Robert J Lentz, Jennifer D Duke, Justin K Siemann, Cristina Salmon, Greta J Dahlberg, Ankush Ratwani, Jonathan D Casey, Heidi Chen, Sheau-Chiann Chen, Samira Shojaee, Otis B Rickman, Cheryl L Gatto, Todd W Rice, Fabien Maldonado\",\"doi\":\"10.1164/rccm.202409-1846OC\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Rationale: </strong>Robotic assisted bronchoscopy has emerged as an alternative to electromagnetic navigational bronchoscopy for patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. While both platforms are routinely used in clinical practice, comparative effectiveness data are lacking.</p><p><strong>Objective: </strong>To compare the effectiveness of robotic assisted and electromagnetic navigational bronchoscopy for evaluation of peripheral pulmonary lesions.</p><p><strong>Methods: </strong>In an investigator-initiated, single-center, cluster randomized noninferiority trial, we assigned patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion to either robotic assisted or electromagnetic navigational bronchoscopy. The cluster randomization unit was the operating room in which patients were scheduled. The primary outcome was the diagnostic yield of the procedure, defined as the proportion of cases yielding lesional tissue. Secondary and safety outcomes included procedure duration and complications.</p><p><strong>Measurements and main results: </strong>Among the 411 patients included in the modified intention to treat analysis, lesional tissue was obtained in 158 of 203 (77.8%) patients in the robotic assisted group and 157 of 208 (75.5%) patients in the electromagnetic group, p-value for non-inferiority 0.007. The median duration of bronchoscopy was 37 minutes in the robotic assisted group and 32 minutes in the electromagnetic group (difference, 5 minutes; 95% confidence interval 2.0 to 7.7). Pneumothorax occurred in 4 patients in the robotic assisted group and 6 patients in the electromagnetic group.</p><p><strong>Conclusions: </strong>In patients undergoing bronchoscopy for the evaluation of a peripheral pulmonary lesion, the diagnostic yield of robotic assisted bronchoscopy was not inferior to that of electromagnetic navigation bronchoscopy. Clinical trial registration available at www.</p><p><strong>Clinicaltrials: </strong>gov, ID: NCT05705544. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).</p>\",\"PeriodicalId\":7664,\"journal\":{\"name\":\"American journal of respiratory and critical care medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":19.4000,\"publicationDate\":\"2025-06-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American journal of respiratory and critical care medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1164/rccm.202409-1846OC\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American journal of respiratory and critical care medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1164/rccm.202409-1846OC","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT).
Rationale: Robotic assisted bronchoscopy has emerged as an alternative to electromagnetic navigational bronchoscopy for patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. While both platforms are routinely used in clinical practice, comparative effectiveness data are lacking.
Objective: To compare the effectiveness of robotic assisted and electromagnetic navigational bronchoscopy for evaluation of peripheral pulmonary lesions.
Methods: In an investigator-initiated, single-center, cluster randomized noninferiority trial, we assigned patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion to either robotic assisted or electromagnetic navigational bronchoscopy. The cluster randomization unit was the operating room in which patients were scheduled. The primary outcome was the diagnostic yield of the procedure, defined as the proportion of cases yielding lesional tissue. Secondary and safety outcomes included procedure duration and complications.
Measurements and main results: Among the 411 patients included in the modified intention to treat analysis, lesional tissue was obtained in 158 of 203 (77.8%) patients in the robotic assisted group and 157 of 208 (75.5%) patients in the electromagnetic group, p-value for non-inferiority 0.007. The median duration of bronchoscopy was 37 minutes in the robotic assisted group and 32 minutes in the electromagnetic group (difference, 5 minutes; 95% confidence interval 2.0 to 7.7). Pneumothorax occurred in 4 patients in the robotic assisted group and 6 patients in the electromagnetic group.
Conclusions: In patients undergoing bronchoscopy for the evaluation of a peripheral pulmonary lesion, the diagnostic yield of robotic assisted bronchoscopy was not inferior to that of electromagnetic navigation bronchoscopy. Clinical trial registration available at www.
Clinicaltrials: gov, ID: NCT05705544. This article is open access and distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
期刊介绍：
The American Journal of Respiratory and Critical Care Medicine focuses on human biology and disease, as well as animal studies that contribute to the understanding of pathophysiology and treatment of diseases that affect the respiratory system and critically ill patients. Papers that are solely or predominantly based in cell and molecular biology are published in the companion journal, the American Journal of Respiratory Cell and Molecular Biology. The Journal also seeks to publish clinical trials and outstanding review articles on areas of interest in several forms. The State-of-the-Art review is a treatise usually covering a broad field that brings bench research to the bedside. Shorter reviews are published as Critical Care Perspectives or Pulmonary Perspectives. These are generally focused on a more limited area and advance a concerted opinion about care for a specific process. Concise Clinical Reviews provide an evidence-based synthesis of the literature pertaining to topics of fundamental importance to the practice of pulmonary, critical care, and sleep medicine. Images providing advances or unusual contributions to the field are published as Images in Pulmonary, Critical Care, Sleep Medicine and the Sciences.
A recent trend and future direction of the Journal has been to include debates of a topical nature on issues of importance in pulmonary and critical care medicine and to the membership of the American Thoracic Society. Other recent changes have included encompassing works from the field of critical care medicine and the extension of the editorial governing of journal policy to colleagues outside of the United States of America. The focus and direction of the Journal is to establish an international forum for state-of-the-art respiratory and critical care medicine.
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