Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.

NCT02332863 | Completed Results

• 1 other identifier: 14-1711.cc
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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. 1.Be delivered in at least require 60% less of the procedure time that it takes for traditional back-loaded 22G needles
2. 2.Improve overall procedure efficiency
3. 3.Maintain comparable technical success and adverse event rates.
4. 4.To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers
5. 5.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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Image guided radiation therapy; Fiducial marker placement; Endoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• Procedure Duration Required for Placing the Fiducial Markers

  Duration of procedure for placing fiducial markers including: Fiducial package was opened start time (start stop watch) + Fiducial placement end time (end stop watch) = Placing Fiducial Markers Time

  During scheduled procedure (approximately 1 hour)

Secondary Outcomes (7)

• Total Procedure Time

  During scheduled procedure (approximately 1 hour)

• Number of Participants With Technical Success EUS Needle Visualization

  During scheduled procedure (approximately 1 hour)

• Technical Success

  During scheduled procedure (approximately 1 hour)

• Number of Participants With Visualization of Fiducials as Assessed by Radiation Oncology

  Several hours to 7 days after fiducial marker deployment

• Number of Participants With Inadvertent Deployment of Fiducials

  During scheduled procedure (approximately 1 hour)

Study Arms (2)

Back-loaded needle

ACTIVE COMPARATOR

The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle. CRFs will be used to record data for primary and secondary endpoints.

Device: Back-loaded Needle (Device)

Preloaded Needle

EXPERIMENTAL

The patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G preloaded needle. CRFs will be used to record data for primary and secondary endpoints.

Device: Preloaded Needle (Device)

Interventions

Back-loaded Needle (Device) DEVICE

Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded: * total length of procedure * how many markers are successfully deployed * technical success Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation.

Back-loaded needle

Preloaded Needle (Device) DEVICE

Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded: * total length of procedure * how many markers are successfully deployed * technical success Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation.

Preloaded Needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically confirmed pancreatic cancer referred for image guided radiation therapy (IGRT)

You may not qualify if:

• Age \<18
• Inability to consent
• Known coagulopathy/thrombocytopenia (INR \>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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cook Group Incorporated: collaborator

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (19)

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  PMID: 31042578 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Sachin Wani
• Organization: University of Colorado - Anschutz Medical Campus

sachin.wani@cuanschutz.edu

720-848-2786

Study Officials

• Sachin Wani, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: January 7, 2015
• Study Start: August 3, 2016
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2020
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-12

Locations

US (2)