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N/A N=608 Randomized Single-blind Diagnostic

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

Pancreatic Masses · Lymph Nodes

Bottom Line

View on ClinicalTrials.gov: NCT02167074 ↗
Enrolled (actual)
608
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Diagnostic Accuracy — 237; 263 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
25G FNA needle (Device); 20G ProCore FNB needle (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Foundation for Liver Research
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Diagnostic Accuracy		 237; 263 —
SECONDARY
Number of Participants in Whom Target Lesion Was Sampled		 306; 298 —
SECONDARY
Presence of Vital Target Cells Per Case, Per Needle Type		 248; 263 <0.05 sig
SECONDARY
Number of Patients With Adverse Events Per Needle Type		 3; 2 —
SECONDARY
Diagnostic Yield of the First Needle Pass		 206; 209 —
SECONDARY
On-site Pathological Evaluation Performed		 74; 26 —

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02167074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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