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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02332863
Collaborator
Cook Group Incorporated (Industry)
44
2
2
44.9
22
0.5

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Back-loaded Needle (Device)
  • Device: Preloaded Needle (Device)
N/A

Detailed Description

Pancreatic cancer is the twelfth most common cancer worldwide. Neoadjuvant chemoradiation therapy in patients with borderline resectable pancreatic adenocarcinoma has become standard of care and is associated with higher rates of complete resection ultimately with improvement of overall survival in this patient population. Radiation therapy to a soft tissue organ such as the pancreas can be difficult, as it is not readily visualized radiographically. Image guided radiation therapy (IGRT) is a commonly implemented modality for delivering high doses of radiation directed at cancer tissue, while reducing collateral damage to adjacent healthy tissue. Fiducials, which are inert radiographic markers typically made from gold or carbon, can be placed in and around the tumor to delineate tumor margins to allow for IGRT Endoscopic ultrasound (EUS) has been pivotal in accomplishing IGRT by allowing precise contouring and identification of target lesions in the pancreas via placement of fiducials. This has traditionally been accomplished with the use of 19-gauge or 22-gauge fine needle aspiration (FNA) needles. To prepare the needle for fiducial placement, one to two fiducials are manually back-loaded into the tip of the needle after the stylet has been removed. In order to hold the fiducials within the needle, sterile lubrication or bone wax can be applied. Once the pancreatic mass has been targeted, fiducial injection can be accomplished via stylet reinsertion or sterile water injection. Currently, back-loading the fiducials is the only option for preparing delivery of fiducials via the EUS approach. Difficulties associated with fiducial loading and deployment can increase procedure duration due to cumbersome fiducial back-loading, fiducial misplacement & migration, as well as inability to pass the fiducial marker through the needle due to endoscope angulation. Observational studies have sited a technical success rate of 86-100% using 19 and/or 22 gauge needles with average procedure time between 7-12 minutes using the fiducial back-loading technique.

A new mode of fiducial delivery has recently been developed that hopes to circumvent some of the technical issues inherent to traditional fiducial marker loading and deployment. A prototype 22-Gauge EUS needle preloaded with four fiducials has been used in a porcine models with successful deployment 95.6% of the time all accurate on predetermined targets. They were deemed easy to pass, relatively easy to deploy, and easily visualized on EUS, with excellent fluoroscopic and CT visualization. In addition, time for deployment was on average less than 60 seconds.

To date, there is 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.

This will be a multicenter randomized controlled trial. Randomization be performed and patients will undergo Linear EUS and have fiducial marker placement via a traditional 22G back-loaded needle (Visicoil) or the new 22G preloaded needle (PreLoad4). Multiple endpoints will be recorded, including total length of procedure, how many markers are successfully deployed, and technical success (Ease of passage of delivery system, ease of deployment of fiducials, EUS visualization of delivery system needle, EUS visual appearance of fiducials, and time for fiducial placement defined as starting at time of removing the needle from its packaging and ending time as removal of needle after final marker deployment). 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. Patients will be discharged home after post procedure recovery. Patients will be contacted at home by a research coordinator or endoscopy staff 24-48 hours and 7-10 days after the procedure to document any immediate and delayed complications. Patients will return for their IGRT visit, and any evidence of fiducial marker migration will be recorded by the radiation oncologist.

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 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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Aug 3, 2016
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Back-loaded needle

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)
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.

Experimental: Preloaded Needle

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)
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.

Outcome Measures

Primary Outcome Measures

  1. Procedure Duration Required for Placing the Fiducial Markers [During scheduled procedure (approximately 1 hour)]

    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

Secondary Outcome Measures

  1. Total Procedure Time [During scheduled procedure (approximately 1 hour)]

    Total procedure time will be recorded during the procedure using a case report form (CRF) for Procedure Time

  2. Number of Participants With Technical Success EUS Needle Visualization [During scheduled procedure (approximately 1 hour)]

    EUS needle visualization during the procedure will be recorded on a CRF for Scale of Technical Success.

  3. Technical Success [During scheduled procedure (approximately 1 hour)]

    Defined as the proper placement of 3 fiducial markers in a pancreatic neoplasm in 2 different planes

  4. Number of Participants With Visualization of Fiducials as Assessed by Radiation Oncology [Several hours to 7 days after fiducial marker deployment]

    Fiducial location on CT scan will be assessed at patient's radiation oncology appointments for IGRT.

  5. Number of Participants With Inadvertent Deployment of Fiducials [During scheduled procedure (approximately 1 hour)]

    Whether inadvertent deployment of fiducials occurs will be recorded on a CRF for Data Acquisition

  6. Number of Participants With Ease of Passage of Delivery System [During scheduled procedure (approximately 1 hour)]

    Ease of needle device passage through EUS will be recorded on a CRF form for technical success.

  7. Number of Fiducials Placed [During scheduled procedure (about 90 minutes)]

    Number of fiducials placed will be recorded during the procedure using a case report form (CRF) for Fiducial Placement Data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Hospital Aurora Colorado United States 80045
2 Moffitt Cancer Center Tampa Florida United States 33612

Sponsors and Collaborators

  • University of Colorado, Denver
  • Cook Group Incorporated

Investigators

  • Principal Investigator: Sachin Wani, MD, University of Colorado, Denver

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02332863
Other Study ID Numbers:
  • 14-1711.cc
First Posted:
Jan 7, 2015
Last Update Posted:
Dec 9, 2020
Last Verified:
Dec 1, 2020
Keywords provided by University of Colorado, Denver
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
STARTED 22 22
COMPLETED 22 22
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Back-loaded Needle Preloaded Needle Total
Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Participants 22 22 44
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
10
45.5%
8
36.4%
18
40.9%
>=65 years
12
54.5%
14
63.6%
26
59.1%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
66
67
66
Sex: Female, Male (Count of Participants)
Female
11
50%
12
54.5%
23
52.3%
Male
11
50%
10
45.5%
21
47.7%
Race/Ethnicity, Customized (Count of Participants)
White
18
81.8%
21
95.5%
39
88.6%
Black
2
9.1%
0
0%
2
4.5%
Hispanic
2
9.1%
0
0%
2
4.5%
Other
0
0%
1
4.5%
1
2.3%
Region of Enrollment (participants) [Number]
United States
22
100%
22
100%
44
100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
25.8
(6.3)
23.6
(4.2)
24.7
(5.4)

Outcome Measures

1. Primary Outcome
Title Procedure Duration Required for Placing the Fiducial Markers
Description 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
Time Frame During scheduled procedure (approximately 1 hour)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Median (Inter-Quartile Range) [mintues]
16
9
2. Secondary Outcome
Title Total Procedure Time
Description Total procedure time will be recorded during the procedure using a case report form (CRF) for Procedure Time
Time Frame During scheduled procedure (approximately 1 hour)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Median (Inter-Quartile Range) [minutes]
27
25
3. Secondary Outcome
Title Number of Participants With Technical Success EUS Needle Visualization
Description EUS needle visualization during the procedure will be recorded on a CRF for Scale of Technical Success.
Time Frame During scheduled procedure (approximately 1 hour)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Count of Participants [Participants]
16
72.7%
14
63.6%
4. Secondary Outcome
Title Technical Success
Description Defined as the proper placement of 3 fiducial markers in a pancreatic neoplasm in 2 different planes
Time Frame During scheduled procedure (approximately 1 hour)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Count of Participants [Participants]
22
100%
20
90.9%
5. Secondary Outcome
Title Number of Participants With Visualization of Fiducials as Assessed by Radiation Oncology
Description Fiducial location on CT scan will be assessed at patient's radiation oncology appointments for IGRT.
Time Frame Several hours to 7 days after fiducial marker deployment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Count of Participants [Participants]
20
90.9%
19
86.4%
6. Secondary Outcome
Title Number of Participants With Inadvertent Deployment of Fiducials
Description Whether inadvertent deployment of fiducials occurs will be recorded on a CRF for Data Acquisition
Time Frame During scheduled procedure (approximately 1 hour)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Count of Participants [Participants]
1
4.5%
1
4.5%
7. Secondary Outcome
Title Number of Participants With Ease of Passage of Delivery System
Description Ease of needle device passage through EUS will be recorded on a CRF form for technical success.
Time Frame During scheduled procedure (approximately 1 hour)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Easy/minimal difficulty
21
95.5%
15
68.2%
Moderate/significant difficulty
1
4.5%
6
27.3%
Unable to pass needle
0
0%
1
4.5%
8. Secondary Outcome
Title Number of Fiducials Placed
Description Number of fiducials placed will be recorded during the procedure using a case report form (CRF) for Fiducial Placement Data
Time Frame During scheduled procedure (about 90 minutes)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
Measure Participants 22 22
Median (Inter-Quartile Range) [fiducials]
3
3

Adverse Events

Time Frame Immediately after the procedure 24-48 hours after the procedure 7-10 days after the procedure
Adverse Event Reporting Description Study coordinators assessed for procedure-related AEs immediately after, 24-48 hours, and at 5-7 days, with a structured questionnaire. AEs at 24-48 hours and at 5-7 days were assessed through a telephone call.
Arm/Group Title Back-loaded Needle Preloaded Needle
Arm/Group Description 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. 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. 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. 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.
All Cause Mortality
Back-loaded Needle Preloaded Needle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/22 (0%) 0/22 (0%)
Serious Adverse Events
Back-loaded Needle Preloaded Needle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/22 (0%) 0/22 (0%)
Other (Not Including Serious) Adverse Events
Back-loaded Needle Preloaded Needle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 19/22 (86.4%) 16/22 (72.7%)
Gastrointestinal disorders
Abdominal Pain 11/22 (50%) 8/22 (36.4%)
Nausea and/or vomiting 6/22 (27.3%) 3/22 (13.6%)
Other 2/22 (9.1%) 5/22 (22.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Sachin Wani
Organization University of Colorado - Anschutz Medical Campus
Phone 720-848-2786
Email sachin.wani@cuanschutz.edu
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02332863
Other Study ID Numbers:
  • 14-1711.cc
First Posted:
Jan 7, 2015
Last Update Posted:
Dec 9, 2020
Last Verified:
Dec 1, 2020