Peripheral Pulmonary Lesions (PPLs)
Conditions
Keywords
Peripheral pulmonary lesion, Robotic assisted bronchoscopy, Rapid onsite evaluation
Brief summary
ARTEMIS is a multicenter randomized controlled trial. The goal is to understand whether rapid onsite evaluation during robotic assisted bronchoscopy improves the diagnostic performance of the procedure or not.
Detailed description
Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. Robotic assisted bronchoscopy (RAB) with integrated cone beam computed tomography (CBCT) has achieved diagnostic yields exceeding 80% in some studies, significantly higher than traditional methods without advanced imaging, due to the added ability to correct alignment of the bronchoscopy catheter with the target lesion in real-time. Given this, the added value of rapid on-site cytologic evaluation (ROSE) with modern bronchoscopy is an area of debate. ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy. This study will aim to test the hypothesis that modern bronchoscopy done without ROSE guidance is non-inferior to bronchoscopy with ROSE available. Patients undergoing RAB to biopsy a lung lesion will be approached for enrollment and assigned to either ROSE vs no ROSE if they agree to participate. Randomization will be revealed before procedures are started. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.
Interventions
OTHERRapid onsite evaluation
ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy
Sponsors
Vanderbilt University Medical Center
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
It is not possible to blind the bronchoscopist given the nature of the intervention. However, patients and thoracic pathologists (outcome adjudicators) will remain blinded.
Intervention model description
This study is a pragmatic 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 * Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion
Exclusion criteria
* Declines to participate or inability to provide informed consent. * Clinician determination that the use of ROSE is required or contraindicated for the optimal care of an individual patient * Patient enrolled in another trial that requires ROSE for PPL biopsy * Patient previously consented for this trial * Pregnant or incarcerated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Strict 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: 1. Malignancy 2. Specific benign pathologic findings including: organizing pneumonia, frank purulence/robust neutrophilic inflammation with a pathogen isolated, granulomatous inflammation, hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sufficiency of malignant specimens for Next-Generation Sequencing | 30 days post procedure | Proportion of malignant biopsies with sufficient material to send for NGS |
Countries
United States
Contacts
CONTACTSanja Antic Research coordinator
CONTACTRafael Paez Co-PI, MD
PRINCIPAL_INVESTIGATORFabien Maldonado, MD
Vanderbilt University Medical Center
Outcome results
None listed