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RCT: Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses

This study has been completed.
Asan Medical Center
National Taiwan University Hospital
Information provided by (Responsible Party):
Changi General Hospital Identifier:
First received: February 20, 2014
Last updated: July 27, 2015
Last verified: July 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 Preliminary unpublished retrospective data suggested the yield might be raised.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 Intervention Phase
Pancreatic Neoplasm
Pancreatic Diseases
Device: Needle with sideport (NA-230H-8020)
Device: Needle without sideport (NA-220H-8022)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • diagnostic accuracy [ Time Frame: within 1 month after EUSFNA and cytological assessment ]
    Compare the overall diagnostic accuracy rate between both needles

Enrollment: 40
Study Start Date: April 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • all patients referred for EUSFNA of pancreatic masses
  • informed consent is obtained for performance of EUSFNA.

Exclusion criteria:

  • presence of active gastrointestinal bleeding
  • presence of coagulopathy as defined by platelet count <50000/mm3 or/ and international normalized ratio >1.5
  • the current use of thienopyridines (e. g. clopidogrel) in patents requiring antiplatelet therapy8
  • absence of procedural informed consent.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02092519

Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
Asan Medical Center
National Taiwan University Hospital
Principal Investigator: Tiing Leong Ang, MD Changi General Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Changi General Hospital Identifier: NCT02092519     History of Changes
Other Study ID Numbers: ATL2012/312/E
Study First Received: February 20, 2014
Last Updated: July 27, 2015

Keywords provided by Changi General Hospital:
endoscopic ultrasound
pancreatic masses

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases processed this record on April 26, 2017