Lung Nodule, Solitary, Peripheral Pulmonary Lesion
Conditions
Keywords
Electromagnetic navigation bronchoscopy, Robotic assisted bronchoscopy, Cone beam computed tomography, Diagnostic yield
Brief summary
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.
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.
Interventions
DEVICERobotic assisted bronchoscopy (RAB)
Participants allocated to the robotic assisted bronchoscopy arm will undergo robotic assisted bronchoscopy with integrated cone beam computed tomography
Participants allocated to the electromagnetic navigation bronchoscopy arm will undergo electromagnetic navigation bronchoscopy with integrated digital tomosynthesis
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, 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.
Intervention model description
This study will be performed as a pragmatic, cluster randomized controlled trial with parallel group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * Patients enrolled in another trial which requires the use of one specific navigational platform
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue. | 7 days post-procedure | Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified: * Malignancy * Specific benign pathologic findings including: * Organizing pneumonia * Frank purulence/robust neutrophilic inflammation * Granulomatous inflammation * Other specific benign findings such as hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns as adjudicated by an expert lung pathologist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of bronchoscopy (in minutes) | Duration of procedure, approximately 60 minutes | Defined as time from the start of airway registration to the removal of the bronchoscope after completion of navigation procedures |
Countries
United States
Outcome results
None listed