Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT using integrated intraprocedural imaging: study protocol for the RELIANT 2 trial.

BackgroundRobotic assisted bronchoscopy (RAB) and electromagnetic navigational bronchoscopy (ENB) are two approaches to biopsy peripheral pulmonary lesions (PPLs). A recently completed cluster randomized controlled trial, RELIANT (NCT05705544), showed no difference in diagnostic yield between these two modalities. The ENB platform used in RELIANT included integrated digital tomosynthesis, allowing for real-time assessment of PPL location for more precise targeting at the time of biopsy. RAB has since been integrated with cone beam computed tomography (CBCT) to accomplish the same intraprocedural correction. It is unclear if the diagnostic yield of RAB with integrated CBCT (RAB-CBCT) is superior to ENB with integrated digital tomosynthesis (ENB-DT). MethodsRobotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT using integrated intraprocedural imaging (RELIANT 2) is an investigator-initiated, multicenter, open label, superiority, cluster randomized trial. At each participating institution, procedural rooms are randomly assigned to either RAB-CBCT or ENB-DT, with each procedure room-day considered a cluster. All adult patients undergoing navigational bronchoscopy for evaluation of PPL(s) are eligible. Allocation is concealed from schedulers, proceduralists, and patients until the morning of procedure when each room is randomized to a platform. The primary endpoint is the diagnostic yield, defined as the proportion of cases yielding a specific benign or malignant diagnosis per current ATS/ACCP definition. Secondary and safety endpoints include procedure duration and procedural complications. Enrollment began on November 11, 2024 and is expected to enroll approximately 440 patients in 220 clusters. DiscussionRELIANT 2 is an ongoing cluster randomized trial comparing the diagnostic yield of RAB-CBCT to that of ENB-DT in patients undergoing bronchoscopy to biopsy PPLs. This trial will help address some of the limitations of the recently published RELIANT trial. Trial RegistrationThe trial was registered in ClinicalTrials.gov (NCT06654271) on October 21, 2024, prior to patient enrollment.