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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02092519
First Posted: March 20, 2014
Last Update Posted: July 29, 2015
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Asan Medical Center
National Taiwan University Hospital
Information provided by (Responsible Party):
Changi General Hospital
  Purpose

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 Preliminary unpublished retrospective data suggested the yield might be raised.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 (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

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


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT02092519     History of Changes
Other Study ID Numbers: ATL2012/312/E
First Submitted: February 20, 2014
First Posted: March 20, 2014
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Changi General Hospital:
EUSFNA
endoscopic ultrasound
pancreatic masses

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases