The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02167074




Registration number
NCT02167074
Ethics application status
Date submitted
12/06/2014
Date registered
18/06/2014
Date last updated
25/03/2020

Titles & IDs
Public title
Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS
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
Secondary ID [1] 0 0
ASPRO-2014-01
Universal Trial Number (UTN)
Trial acronym
ASPRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Masses 0 0
Lymph Nodes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic Accuracy - 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
Timepoint [1] 0 0
27 months
Secondary outcome [1] 0 0
Number of Participants in Whom Target Lesion Was Sampled - records if a target lesion was reached during the procedure using the randomised needle or not
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Presence of Vital Target Cells Per Case, Per Needle Type - Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
Timepoint [2] 0 0
after 27 months
Secondary outcome [3] 0 0
Number of Patients With Adverse Events Per Needle Type - adverse events per needle type, up to 27 months after procedure
Timepoint [3] 0 0
27 months after procedure
Secondary outcome [4] 0 0
Diagnostic Yield of the First Needle Pass - Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not
Timepoint [4] 0 0
after 27 months
Secondary outcome [5] 0 0
On-site Pathological Evaluation Performed - Presence of pathologist on site during procedure
Timepoint [5] 0 0
27 months

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
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
France
State/province [5] 0 0
Marseille
Country [6] 0 0
Israel
State/province [6] 0 0
Tel Aviv
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
Italy
State/province [8] 0 0
Rome
Country [9] 0 0
Japan
State/province [9] 0 0
Osaka-sayama
Country [10] 0 0
Netherlands
State/province [10] 0 0
Zuid-Holland
Country [11] 0 0
Spain
State/province [11] 0 0
Santiago De Compostela
Country [12] 0 0
Sweden
State/province [12] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Other
Name
Foundation for Liver Research
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Cook Ireland, Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02167074
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marco J Bruno, MD, PhD
Address 0 0
Erasmus Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications