Peripheral pulmonary lesions (PPLs) are often biopsied to assess for the presence of
infection, inflammation, or malignancy. Tissue can be acquired in a variety of ways:
surgical resection, percutaneous transthoracic needle biopsy, or bronchoscopic biopsy.
Bronchoscopy is commonly pursued to determine PPL etiology, with over 500,000 performed
annually in the US alone. Advanced imaging and navigational guidance systems are required
to accurately approach small peripheral lesions bronchoscopically. A variety of
navigational technologies are currently available, including electromagnetic navigational
bronchoscopy (EMN), virtual bronchoscopy, thin and ultrathin bronchoscopes, and
endobronchial ultrasound. No comparative data exist regarding the relative performance of
these competing technologies, which are all considered standard of care and currently
used interchangeably based on personal preferences and availability.
EMN platforms dominate the current navigational bronchoscopy market. The largest
prospective multicenter study assessing EMN performance showed a diagnostic yield of 73%.
The more recent addition of intraprocedural digital tomosynthesis has been reported to
increase EMN diagnostic yield to 75-83%; this feature is included in the ILLUMISITE™
electromagnetic navigational bronchoscopy platform (Medtronic, Minneapolis, MN, U.S.) and
is labeled "fluoroscopic navigation".
Recently, the FDA cleared a novel navigational technology: shape-sensing catheter
bronchoscopy (SSCB), via the 510(k) pathway. This pathway requires a technical
demonstration of safety and efficacy similar to that of an existing predicate device but
does not usually require clinical data. Since market release in 2019, single-center
prospective cohort data have emerged suggesting SSCB diagnostic yield is comparable to
EMN, but no high-quality comparative data exist regarding the relative performance of
these two technologies. Despite this important knowledge/data gap, SSCB has become a
popular platform in the advanced bronchoscopist community. High-quality comparative data
are required to inform optimal patient care. Additionally, EMN and SSCB platforms are
considered capital purchases, each costing hundreds of thousands of dollars. Hence, it is
also important for health care systems to have high quality data as they consider device
purchases. VUMC currently utilizes both SSCB and EMN and they are used interchangeably in
our two operating rooms. Patients are typically assigned arbitrarily to procedures using
either platform based on operating room availability.
Thus, the investigator proposes a randomized controlled study to test the hypothesis that
the diagnostic yield of SSCB is not inferior to EMN in patients undergoing bronchoscopy
to biopsy a PPL.