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Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial

BACKGROUND: Robotic assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclea...

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Autores principales: Paez, Rafael, Lentz, Robert J, Salmon, Cristina, Siemann, Justin K, Low, See-Wei, Casey, Jonathan D, Chen, Heidi, Chen, Sheau-Chiann, Avasarala, Sameer, Shojaee, Samira, Rickman, Otis B, Lindsell, Christopher J, Gatto, Cheryl L, Rice, Todd W, Maldonado, Fabien
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Journal Experts 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10491348/
https://www.ncbi.nlm.nih.gov/pubmed/37693467
http://dx.doi.org/10.21203/rs.3.rs-3222369/v1
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author Paez, Rafael
Lentz, Robert J
Salmon, Cristina
Siemann, Justin K
Low, See-Wei
Casey, Jonathan D
Chen, Heidi
Chen, Sheau-Chiann
Avasarala, Sameer
Shojaee, Samira
Rickman, Otis B
Lindsell, Christopher J
Gatto, Cheryl L
Rice, Todd W
Maldonado, Fabien
author_facet Paez, Rafael
Lentz, Robert J
Salmon, Cristina
Siemann, Justin K
Low, See-Wei
Casey, Jonathan D
Chen, Heidi
Chen, Sheau-Chiann
Avasarala, Sameer
Shojaee, Samira
Rickman, Otis B
Lindsell, Christopher J
Gatto, Cheryl L
Rice, Todd W
Maldonado, Fabien
author_sort Paez, Rafael
collection PubMed
description BACKGROUND: Robotic assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. METHODS: Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room is assigned to either robotic assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. DISCUSSION: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic assisted bronchoscopy. TRIAL REGISTRATION: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023.
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spelling pubmed-104913482023-09-09 Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial Paez, Rafael Lentz, Robert J Salmon, Cristina Siemann, Justin K Low, See-Wei Casey, Jonathan D Chen, Heidi Chen, Sheau-Chiann Avasarala, Sameer Shojaee, Samira Rickman, Otis B Lindsell, Christopher J Gatto, Cheryl L Rice, Todd W Maldonado, Fabien Res Sq Article BACKGROUND: Robotic assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy. METHODS: Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room is assigned to either robotic assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024. DISCUSSION: RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic assisted bronchoscopy. TRIAL REGISTRATION: ClinicalTrials.gov registration (NCT05705544) on January 30, 2023. American Journal Experts 2023-08-28 /pmc/articles/PMC10491348/ /pubmed/37693467 http://dx.doi.org/10.21203/rs.3.rs-3222369/v1 Text en https://creativecommons.org/licenses/by/4.0/This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/) , which allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use.
spellingShingle Article
Paez, Rafael
Lentz, Robert J
Salmon, Cristina
Siemann, Justin K
Low, See-Wei
Casey, Jonathan D
Chen, Heidi
Chen, Sheau-Chiann
Avasarala, Sameer
Shojaee, Samira
Rickman, Otis B
Lindsell, Christopher J
Gatto, Cheryl L
Rice, Todd W
Maldonado, Fabien
Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial
title Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial
title_full Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial
title_fullStr Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial
title_full_unstemmed Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial
title_short Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial
title_sort robotic versus electromagnetic bronchoscopy for pulmonary lesion assessment: the reliant pragmatic randomized trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10491348/
https://www.ncbi.nlm.nih.gov/pubmed/37693467
http://dx.doi.org/10.21203/rs.3.rs-3222369/v1
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