title: Evaluation of a new endoscopic ultrasound-guided multi-fiducial delivery system: a prospective non-survival study in a live porcine model.
abstract: BACKGROUND
  Endoscopic ultrasound (EUS) is an excellent tool for implanting fiducials for gastrointestinal malignancies, but a dedicated delivery system for EUS-guided fiducial placement is not available. The aim of the present study was to evaluate the performance characteristics of a new dedicated EUS-guided multi-fiducial delivery system.
  
  
  METHODS
  This was a prospective live porcine study using prototype 22-G EUS needles preloaded with four fiducials. Primary outcomes were technical success and accuracy of fiducial placement. Secondary outcomes were ease of passage of delivery system, ease of deployment, EUS visualization of the needle, visual appearance of fiducials on EUS, fluoroscopy and computed tomography (CT) scans, time taken for fiducial placement and adverse events. Outcomes were scored on a predetermined 5-point Likert scale (1 = best, 5 = worst).
  
  
  RESULTS
  Fiducial deployment was successful in 43 out of 45 needles (95.6%). All 172 fiducials (43 needles, four fiducials each)were successfully deployed on target. Fiducial placement accuracy score was 1.30 ± 0.64. All needles passed with ease (score 1.0 ± 0.0). Ease of fiducial deployment score was 1.85 ± 1.02. Mean scores for EUS visualization of the needle and fiducial were 1.02 ± 0.15 and 2.10 ± 0.91, respectively. Fluoroscopic and CT visualization of fiducials was excellent. Time for placement of four fiducials was <1 min (0.86 ± 0.50 min). No adverse events were seen.
  
  
  CONCLUSIONS
  The new EUS-guided multi-fiducial delivery system provided quick, easy, and accurate fiducial deployment without adverse events.
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, University of Florida, Gainesville, USA.
authors.forename: Peter V
authors.initials: PV
authors.lastname: Draganov
authors.forename: Disaya
authors.initials: D
authors.lastname: Chavalitdhamrong
authors.forename: Mihir S
authors.initials: MS
authors.lastname: Wagh
mesh_terms: D000818:Animals; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D004867:Equipment Design; D005260:Female; D057918:Fiducial Markers; D021621:Imaging, Three-Dimensional / Q000379:methods; D023421:Models, Animal; D009339:Needles; D011446:Prospective Studies; D061089:Radiotherapy, Image-Guided / Q000295:instrumentation*; D013552:Swine; D014057:Tomography, X-Ray Computed; D014463:Ultrasonography / Q000379:methods*
keywords: delivery system; endoscopic ultrasound; fiducial marker; fiducial placement; needle