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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02167074
Registration number
NCT02167074
Ethics application status
Date submitted
12/06/2014
Date registered
18/06/2014
Date last updated
23/08/2021
Titles & IDs
Public title
Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS
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Scientific title
A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device
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Secondary ID [1]
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ASPRO-2014-01
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Universal Trial Number (UTN)
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Trial acronym
ASPRO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Masses
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Lymph Nodes
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - 25G FNA needle
Treatment: Devices - 20G ProCore FNB needle
Active Comparator: 25G FNA needle - Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).
Active Comparator: 20G ProCore FNB needle - Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).
Treatment: Devices: 25G FNA needle
Treatment: Devices: 20G ProCore FNB needle
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Diagnostic Accuracy
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Assessment method [1]
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Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis
Gold standard diagnosis is defined as;
in operated patients; based on the surgical resection specimen
in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months
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Timepoint [1]
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27 months
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Secondary outcome [1]
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Number of Participants in Whom Target Lesion Was Sampled
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Assessment method [1]
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records if a target lesion was reached during the procedure using the randomised needle or not
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Timepoint [1]
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1 day
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Secondary outcome [2]
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Presence of Vital Target Cells Per Case, Per Needle Type
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Assessment method [2]
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Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
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Timepoint [2]
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after 27 months
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Secondary outcome [3]
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Number of Patients With Adverse Events Per Needle Type
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Assessment method [3]
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adverse events per needle type, up to 27 months after procedure
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Timepoint [3]
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27 months after procedure
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Secondary outcome [4]
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Diagnostic Yield of the First Needle Pass
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Assessment method [4]
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Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not
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Timepoint [4]
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after 27 months
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Secondary outcome [5]
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On-site Pathological Evaluation Performed
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Assessment method [5]
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Presence of pathologist on site during procedure
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Timepoint [5]
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27 months
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Eligibility
Key inclusion criteria
- Patients referred for EUS-guided tissue acquisition because of a (I) pancreatic mass
lesion or (II) lymph node
- Age > 18 years
- Written informed consent
- Lesion can be visualized with EUS and is =1 cm in size
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh
frozen plasma (FFP)
- Use of anticoagulants that cannot be discontinued in order to guarantee an INR below
1.5
- Purely cystic lesions
- Previous inclusion in the current study
- Pregnancy
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2017
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Sample size
Target
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Accrual to date
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Final
615
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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Belgium
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State/province [4]
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Leuven
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Country [5]
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France
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State/province [5]
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Marseille
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Country [6]
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Israel
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State/province [6]
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Tel Aviv
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Country [7]
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Italy
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State/province [7]
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Milan
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Country [8]
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Italy
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State/province [8]
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Rome
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Country [9]
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Japan
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State/province [9]
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Osaka-sayama
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Country [10]
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Netherlands
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State/province [10]
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Zuid-Holland
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Country [11]
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Spain
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State/province [11]
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Santiago De Compostela
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Country [12]
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Sweden
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State/province [12]
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Stockholm
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Funding & Sponsors
Primary sponsor type
Other
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Name
Foundation for Liver Research
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Cook Ireland, Ltd.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue
acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G
Echotip ProCore Fine Needle Biopsy (FNB) device.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02167074
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marco J Bruno, MD, PhD
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Address
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Erasmus Medical Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02167074
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