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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnostic Accuracy
Timepoint [1] 0 0
27 months
Secondary outcome [1] 0 0
Number of Participants in Whom Target Lesion Was Sampled
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Presence of Vital Target Cells Per Case, Per Needle Type
Timepoint [2] 0 0
after 27 months
Secondary outcome [3] 0 0
Number of Patients With Adverse Events Per Needle Type
Timepoint [3] 0 0
27 months after procedure
Secondary outcome [4] 0 0
Diagnostic Yield of the First Needle Pass
Timepoint [4] 0 0
after 27 months
Secondary outcome [5] 0 0
On-site Pathological Evaluation Performed
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
Sex
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
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
615
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02167074