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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Changi General Hospital
Sponsor:
Collaborators:
Asan Medical Center
National Taiwan University Hospital
Information provided by (Responsible Party):
Changi General Hospital
ClinicalTrials.gov Identifier:
NCT02092519
First received: February 20, 2014
Last updated: March 18, 2014
Last verified: March 2014
  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 Preliminary unpublished retrospective data suggested the yield might be raised.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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Changi General Hospital:

Primary Outcome Measures:
  • diagnostic accuracy [ Time Frame: within 1 month after EUSFNA and cytological assessment ] [ Designated as safety issue: No ]
    Compare the overall diagnostic accuracy rate between both needles


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092519

Contacts
Contact: Tiing Leong Ang, MD +6568503558 tiing_leong_ang@cgh.com.sg

Locations
Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Tiing Leong Ang, MD    +6568503558    tiing_leong_ang@cgh.com.sg   
Principal Investigator: Tiing Leong Ang, MD         
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:
Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT02092519     History of Changes
Other Study ID Numbers: ATL2012/312/E
Study First Received: February 20, 2014
Last Updated: March 18, 2014
Health Authority: Singapore: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014