Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS (ASPRO)

August 19, 2021 updated by: Foundation for Liver Research

A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device

The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Fine needle aspiration (FNA) provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, FNB needles are stiffer and more difficult to handle, which can complicate tissue acquisition. In addition, the superiority of histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance, tissue, obtained by FNA and processed with the new cell-block technique, may equal the diagnostic yield of histological tissue cores.

A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an adequate cytological specimen. In this study, we aim to compare the properties and merits of a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA device.

Study Type

Interventional

Enrollment (Actual)

615

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • The Royal Adelaide Hospital
  • Belgium
      • Leuven, Belgium
        • University Hospital Leuven
  • France
      • Marseille, France
        • Institut Paoli-Calmettes
  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Milan, Italy
        • Vita Salute San Raffaele University
      • Rome, Italy
        • Catholic University Rome
  • Japan
      • Osaka-sayama, Japan
        • Kinki University
  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 CE
        • Erasmus University Medical Center
  • Spain
      • Santiago De Compostela, Spain
        • University Hospital of Santiago de Compostella
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • United States
    • California
      • Irvine, California, United States, CA 92868
        • University of California
    • Connecticut
      • New Haven, Connecticut, United States, CT 06520
        • Yale University School of Medicine
    • New York
      • New York, New York, United States, NY 11794
        • Stony Brook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Device: 25G FNA needle
Other Names:
  • 25G Echotip Ultra Fine Needle Aspiration (FNA) device
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).
Device: 20G ProCore FNB needle
Other Names:
  • 20G Echotip ProCore Fine Needle Biopsy (FNB) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy
Time Frame: 27 months

Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis

Gold standard diagnosis is defined as;

  1. in operated patients; based on the surgical resection specimen
  2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months
27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in Whom Target Lesion Was Sampled
Time Frame: 1 day
records if a target lesion was reached during the procedure using the randomised needle or not
1 day
Presence of Vital Target Cells Per Case, Per Needle Type
Time Frame: after 27 months
Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
after 27 months
Number of Patients With Adverse Events Per Needle Type
Time Frame: 27 months after procedure
adverse events per needle type, up to 27 months after procedure
27 months after procedure
Diagnostic Yield of the First Needle Pass
Time Frame: after 27 months
Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not
after 27 months
On-site Pathological Evaluation Performed
Time Frame: 27 months
Presence of pathologist on site during procedure
27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Liver Research

Collaborators

Cook Ireland, Ltd.

Investigators

  • Study Chair: Marco J Bruno, MD, PhD, Erasmus Medical Center
  • Principal Investigator: Djuna L Cahen, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ASPRO-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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