Trial Outcomes & Findings for Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer. (NCT NCT02332863)
NCT ID: NCT02332863
Last Updated: 2020-12-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
During scheduled procedure (approximately 1 hour)
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.
Baseline characteristics by cohort
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.8 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
24.7 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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.
|
|---|---|---|
|
Procedure Duration Required for Placing the Fiducial Markers
|
16 mintues
Interval 12.0 to 24.0
|
9 mintues
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: During scheduled procedure (approximately 1 hour)Total procedure time will be recorded during the procedure using a case report form (CRF) for Procedure Time
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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 Procedure Time
|
27 minutes
Interval 23.0 to 28.0
|
25 minutes
Interval 18.0 to 36.0
|
SECONDARY outcome
Timeframe: During scheduled procedure (approximately 1 hour)EUS needle visualization during the procedure will be recorded on a CRF for Scale of Technical Success.
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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.
|
|---|---|---|
|
Number of Participants With Technical Success EUS Needle Visualization
|
16 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: During scheduled procedure (approximately 1 hour)Defined as the proper placement of 3 fiducial markers in a pancreatic neoplasm in 2 different planes
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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.
|
|---|---|---|
|
Technical Success
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Several hours to 7 days after fiducial marker deploymentFiducial location on CT scan will be assessed at patient's radiation oncology appointments for IGRT.
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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.
|
|---|---|---|
|
Number of Participants With Visualization of Fiducials as Assessed by Radiation Oncology
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: During scheduled procedure (approximately 1 hour)Whether inadvertent deployment of fiducials occurs will be recorded on a CRF for Data Acquisition
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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.
|
|---|---|---|
|
Number of Participants With Inadvertent Deployment of Fiducials
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During scheduled procedure (approximately 1 hour)Ease of needle device passage through EUS will be recorded on a CRF form for technical success.
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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.
|
|---|---|---|
|
Number of Participants With Ease of Passage of Delivery System
Easy/minimal difficulty
|
21 Participants
|
15 Participants
|
|
Number of Participants With Ease of Passage of Delivery System
Moderate/significant difficulty
|
1 Participants
|
6 Participants
|
|
Number of Participants With Ease of Passage of Delivery System
Unable to pass needle
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Back-loaded Needle
n=22 Participants
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.
|
Preloaded Needle
n=22 Participants
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.
|
|---|---|---|
|
Number of Fiducials Placed
|
3 fiducials
Interval 3.0 to 4.0
|
3 fiducials
Interval 3.0 to 4.0
|
Adverse Events
Back-loaded Needle
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Preloaded Needle
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Back-loaded Needle
n=22 participants at risk
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.
|
Preloaded Needle
n=22 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
11/22 • Immediately after the procedure 24-48 hours after the procedure 7-10 days after the procedure
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.
|
36.4%
8/22 • Immediately after the procedure 24-48 hours after the procedure 7-10 days after the procedure
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.
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
27.3%
6/22 • Immediately after the procedure 24-48 hours after the procedure 7-10 days after the procedure
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.
|
13.6%
3/22 • Immediately after the procedure 24-48 hours after the procedure 7-10 days after the procedure
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.
|
|
Gastrointestinal disorders
Other
|
9.1%
2/22 • Immediately after the procedure 24-48 hours after the procedure 7-10 days after the procedure
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.
|
22.7%
5/22 • Immediately after the procedure 24-48 hours after the procedure 7-10 days after the procedure
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.
|
Additional Information
Dr. Sachin Wani
University of Colorado - Anschutz Medical Campus
Phone: 720-848-2786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place