Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial
Abstract 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 i...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07863-3 |
| _version_ | 1797349691124350976 |
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| author | Rafael Paez Robert J. Lentz Cristina Salmon Justin K. Siemann See-Wei Low Jonathan D. Casey Heidi Chen Sheau-Chiann Chen Sameer Avasarala Samira Shojaee Otis B. Rickman Christopher J. Lindsell Cheryl L. Gatto Todd W. Rice Fabien Maldonado for the Vanderbilt Learning Healthcare System Platform Investigators |
| author_facet | Rafael Paez Robert J. Lentz Cristina Salmon Justin K. Siemann See-Wei Low Jonathan D. Casey Heidi Chen Sheau-Chiann Chen Sameer Avasarala Samira Shojaee Otis B. Rickman Christopher J. Lindsell Cheryl L. Gatto Todd W. Rice Fabien Maldonado for the Vanderbilt Learning Healthcare System Platform Investigators |
| author_sort | Rafael Paez |
| collection | DOAJ |
| description | Abstract 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 (OR) 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. |
| first_indexed | 2024-03-08T12:34:02Z |
| format | Article |
| id | doaj.art-0da1e295278d4a62abaf5511ef3477ed |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T12:34:02Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-0da1e295278d4a62abaf5511ef3477ed2024-01-21T12:33:52ZengBMCTrials1745-62152024-01-0125111110.1186/s13063-023-07863-3Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trialRafael Paez0Robert J. Lentz1Cristina Salmon2Justin K. Siemann3See-Wei Low4Jonathan D. Casey5Heidi Chen6Sheau-Chiann Chen7Sameer Avasarala8Samira Shojaee9Otis B. Rickman10Christopher J. Lindsell11Cheryl L. Gatto12Todd W. Rice13Fabien Maldonado14for the Vanderbilt Learning Healthcare System Platform InvestigatorsDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical CenterDivision of Pulmonary Medicine, Respiratory Institute, Cleveland ClinicDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterDepartment of Biostatistics, Vanderbilt University Medical CenterDepartment of Biostatistics, Vanderbilt University Medical CenterDivision of Pulmonary, Critical Care, and Sleep Medicine, University Hospitals - Case Western Reserve University School of MedicineDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterDepartment of Biostatistics, Vanderbilt University Medical CenterVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical CenterDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical CenterAbstract 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 (OR) 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.https://doi.org/10.1186/s13063-023-07863-3Electromagnetic navigational bronchoscopyRobotic-assisted bronchoscopyDiagnostic yieldPeripheral pulmonary lesionPragmatic trial |
| spellingShingle | Rafael Paez Robert J. Lentz Cristina Salmon Justin K. Siemann See-Wei Low Jonathan D. Casey Heidi Chen Sheau-Chiann Chen Sameer Avasarala Samira Shojaee Otis B. Rickman Christopher J. Lindsell Cheryl L. Gatto Todd W. Rice Fabien Maldonado for the Vanderbilt Learning Healthcare System Platform Investigators Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial Trials Electromagnetic navigational bronchoscopy Robotic-assisted bronchoscopy Diagnostic yield Peripheral pulmonary lesion Pragmatic 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 | Electromagnetic navigational bronchoscopy Robotic-assisted bronchoscopy Diagnostic yield Peripheral pulmonary lesion Pragmatic trial |
| url | https://doi.org/10.1186/s13063-023-07863-3 |
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