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

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.

Conditions

• Pancreatic Cancer

Interventions

DEVICE

Back-loaded Needle (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.

DEVICE

Preloaded Needle (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.

Sponsors & Collaborators

• Cook Group Incorporated

  collaborator INDUSTRY

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Sachin Wani, MD · University of Colorado, Denver

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-03

Primary Completion

2018-04-30

Completion

2020-05-01

Countries

• United States

Study Locations