N/A
N=44
Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02332863 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Procedure Duration Required for Placing the Fiducial Markers — 16; 9 mintues
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Back-loaded Needle (Device) (Device); Preloaded Needle (Device) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Duration Required for Placing the Fiducial Markers |
16; 9 | — |
| SECONDARY Total Procedure Time |
27; 25 | — |
| SECONDARY Number of Participants With Technical Success EUS Needle Visualization |
16; 14 | — |
| SECONDARY Technical Success |
22; 20 | — |
| SECONDARY Number of Participants With Visualization of Fiducials as Assessed by Radiation Oncology |
20; 19 | — |
| SECONDARY Number of Participants With Inadvertent Deployment of Fiducials |
1; 1 | — |
| SECONDARY Number of Participants With Ease of Passage of Delivery System |
21; 15; 1; 6; 0; 1 | — |
| SECONDARY Number of Fiducials Placed |
3; 3 | — |
Summary
Endoscopic ultrasound (EUS) has been pivotal in accomplishing image guided radiation therapy (IGRT) in patients with pancreatic cancer by allowing precise contouring and identification of target lesions in the pancreas via placement of fiducials using fine needle aspiration (FNA) needles. Currently, back-loading the fiducials is the only option for preparing delivery of fiducials via the EUS approach. A prototype 22-Gauge EUS needle preloaded with four fiducials has recently been developed, and used in a porcine models with successful results. There are no randomized controlled trials comparing total duration of time needed for placement of fiducials using technical success of the traditional back- loading technique of fiducial markers to the new preloaded needles in regards to EUS based fiducial marker placement for IGRT in pancreatic cancer.
Hypotheses
Use of a 22 G preloaded needle for EUS guided fiducial marker placement in patients with pancreatic cancer will:
1. Be delivered in at least require 60% less of the procedure time that it takes for traditional back-loaded 22G needles
2. Improve overall procedure efficiency
3. Maintain comparable technical success and adverse event rates.
Primary Aims
1) To compare the procedure time of 22G needle placement of three Visicoil (brand of flexible linear back-loaded fiducial markers) fiducial markers and 22G needle preloaded fiducial markers.
Secondary Aims
1. To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers
2. To compare endpoints of technical success defined as proper placement of two to three fiducial markers in a pancreatic neoplasm in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers.
Eligibility Criteria
Inclusion Criteria
- Patients with pathologically confirmed pancreatic cancer referred for image guided radiation therapy (IGRT)
Exclusion Criteria
- Age 1.5, platelets <75)
- Patients on antiplatelet/anticoagulant medication that cannot safely be discontinued 5-7 days prior to the procedure
- Gold allergy
- Current infection
- EUS evidence of vessel interfering with path of fiducial marker
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02332863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.