Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
[Preprint]. 2023 Aug 28:rs.3.rs-3222369.
doi: 10.21203/rs.3.rs-3222369/v1.

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

Rafael Paez  1 , Robert J Lentz  1 , Cristina Salmon  1 , Justin K Siemann  1 , See-Wei Low  2 , Jonathan D Casey  1 , Heidi Chen  1 , Sheau-Chiann Chen  1 , Sameer Avasarala  3 , Samira Shojaee  1 , Otis B Rickman  1 , Christopher J Lindsell  1 , Cheryl L Gatto  1 , Todd W Rice  1 , Fabien Maldonado  1
Affiliations

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

Rafael Paez et al. Res Sq. .

Update in

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 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.

Keywords: diagnostic yield; electromagnetic navigational bronchoscopy; peripheral pulmonary lesion; pragmatic trial; robotic-assisted bronchoscopy.

PubMed Disclaimer

Conflict of interest statement

Competing interests {28} RP, RJL, CS, JKS, SWL, JDC, HC, SCC, SA, SS, CJL, CLG, and TWR declare no competing interests. OBR declares: Consultant, research grant and advisory board Medtronic; and Consultant, physician advisory board Intuitive. FM declares: Research funding to my institution for the VERITAS randomized controlled trial; and prior consulting for Medtronic and Intuitive. .

Figures

Figure 1
Figure 1
Standard Protocol Items: Recommendation for Interventional Trials. RELIANT enrolment, intervention, and assessment.
See this image and copyright information in PMC

References

    1. Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, et al. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015;192(10):1208–14. - PubMed
    1. Nadig TR, Thomas N, Nietert PJ, Lozier J, Tanner NT, Wang Memoli JS, Pastis NJ, Silvestri GA. Guided Bronchoscopy for the Evaluation of Pulmonary Lesions: An Updated Meta-analysis. Chest. 2023;163(6):1589–1598. - PubMed
    1. Criner GJ, Eberhardt R, Fernandez-Bussy S, Gompelmann D, Maldonado F, Patel N, et al. Interventional Bronchoscopy. Am J Respir Crit Care Med. 2020;202(1):29–50. - PubMed
    1. Cicenia J, Avasarala SK, Gildea TR. Navigational bronchoscopy: a guide through history, current use, and developing technology. J Thorac Dis. 2020;12(6):3263–71. - PMC - PubMed
    1. Folch EE, Pritchett MA, Nead MA, Bowling MR, Murgu SD, Krimsky WS, et al. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019;14(3):445–58. - PubMed

Publication types

Associated data

LinkOut - more resources