RCT: Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses
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|ClinicalTrials.gov Identifier: NCT02092519|
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : July 29, 2015
Background: EUS-guided fine needle aspiration (EUSFNA) is a well established technique for tissue acquisition and diagnosis with excellent safety profile. The overall diagnostic yield of EUSFNA exceeds 80%, with higher rates in EUSFNA of lymph nodes, where rates of >90% may be expected, as compared to pancreatic masses, where lower diagnostic rates were reported. To maximize the diagnostic yield, at least 3 needle passes are required for lymph nodes and at least 4 passes for pancreatic masses. Olympus has recently made commercially available a new 22 gauge FNA needle (EZ Shot 2 with side port) with a side port at the needle tip. The theoretical basis for introduction of the side port is to increase the diagnostic yield. Preliminary unpublished retrospective data suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption.
Aim: To determine whether there is a difference in diagnostic yield between EZ-Shot 2 and EZ-Shot 2 with side port in patients with pancreatic masses for evaluation.
Methods: Patients with pancreatic masses referred for EUSFNA will be recruited prospectively and randomized to either EZ-Shot 2 or EZ Shot 2 with sideport for the first puncture, and then the alternative needle will be used for repeated punctured. The cytological and diagnostic yield at first pass for both needles will be compared.
Clinical significance: This will determine whether the new needle design can further improve the diagnostic yield of EUSFNA of pancreatic masses.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasm Pancreatic Diseases||Device: Needle with sideport (NA-230H-8020) Device: Needle without sideport (NA-220H-8022)||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Prospective Multi-center Randomized Study of the Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Active Comparator: Needle without sideport (NA-220H-8022)
EUSFNA using needle without sideport (NA-220H-8022)
Device: Needle with sideport (NA-230H-8020)
EUSFNA using needle with sideport
Active Comparator: Needle with sideport (NA-230H-8020)
EUSFNA using needle with sideport (NA-230H-8020)
Device: Needle without sideport (NA-220H-8022)
EUSFNA using needle without sideport
- diagnostic accuracy [ Time Frame: within 1 month after EUSFNA and cytological assessment ]Compare the overall diagnostic accuracy rate between both needles
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092519
|Changi General Hospital|
|Singapore, Singapore, 529889|
|Principal Investigator:||Tiing Leong Ang, MD||Changi General Hospital|