Skip to main content
OpenTrials
Completed

NCT Number: NCT02167074

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

25G FNA needle

Device

Other names: 25G Echotip Ultra Fine Needle Aspiration (FNA) device

20G ProCore FNB needle

Device

Other names: 20G Echotip ProCore Fine Needle Biopsy (FNB) device

Primary outcomes

  1. 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;

    • in operated patients; based on the surgical resection specimen
    • 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. On-site Pathological Evaluation Performed

    Time frame: 27 months

    Presence of pathologist on site during procedure

Sponsors and collaborators

Lead sponsor

Foundation for Liver Research

Other

Collaborators

  • Cook Ireland, Ltd.

Registry information

Official study title

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

Acronym: ASPRO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2014
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.