Robotic Versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT Using Integrated Intraprocedural Imaging
Purpose
RELIANT 2 is a pragmatic randomized controlled trial. The goal of this study is to compare the diagnostic yield of robotic assisted bronchoscopy with integrated cone beam computed tomography to that of electromagnetic navigation bronchoscopy with integrated digital tomosynthesis in patients undergoing bronchoscopy to biopsy a pulmonary lesion.
Conditions
- Peripheral Pulmonary Lesion
- Lung Nodule, Solitary
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 18 years of age at time of bronchoscopy - Scheduled for navigational bronchoscopy for the evaluation of a pulmonary lesion
Exclusion Criteria
- Patient declines to participate
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This study will be performed as a pragmatic, cluster randomized controlled trial with parallel group assignment.
- Primary Purpose
- Diagnostic
- Masking
- Double (Care Provider, Outcomes Assessor)
- Masking Description
- It is not possible to blind the bronchoscopist or the patient to the platform used for each procedure, as they are both large distinctive-appearing pieces of equipment. However, allocation will be concealed until the morning of the procedure. Thoracic pathologists and bronchoscopy schedulers will remain blinded, thus allocations will not influence scheduling of procedures or histopathological interpretation.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Robotic assisted bronchoscopy (RAB) |
Robotic assisted bronchoscopy with integrated cone beam computed tomography |
|
|
Active Comparator Electromagnetic navigation bronchoscopy (ENB) |
Electromagnetic navigation bronchoscopy (ENB) with integrated digital tomosynthesis |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center
Detailed Description
Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. There are several technologies currently available to biopsy these lesions, including electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB). The latter is used clinically with either conventional fluoroscopy or with cone beam computed tomography (CBCT) guidance, which provides real time 3-dimensional images during the procedure. Recently, CBCT has been integrated with RAB, which allows for automatic update of the lesion location. This update is believed to increase the diagnostic yield of the procedure. Given this new upgrade, we designed this pragmatic, randomized controlled study to test the hypothesis that the diagnostic yield of RAB with integrated CBCT is superior to ENB with integrated digital tomosynthesis in patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Patients undergoing advanced diagnostic bronchoscopy to biopsy a lung lesion will be assigned to either the RAB or ENB based on cluster randomization. Randomization will be revealed each morning before procedures are started. Any advanced diagnostic bronchoscopy scheduled on that day will be performed with the device (RAB or ENB) allocated to that room on that day. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.