Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.
Public ClinicalTrials.gov record NCT02332863. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Comparison of Traditional Back-loaded Fiducial Needles With Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement for Image-guided Radiation Therapy in Patients With Pancreatic Cancer: A Multicenter Randomized Controlled Trial.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02332863
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 44 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2, 2016
- Primary completion
- Mar 31, 2018
- Completion
- Apr 30, 2020
- Last update posted
- Dec 8, 2020
2016 – 2020
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02332863, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2020 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02332863 live on ClinicalTrials.gov.