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

Completed · Not applicable

Conditions studied: Pancreatic Masses, Lymph Nodes

In brief

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.

Key facts

Study ID

NCT02167074

Run by

Foundation for Liver Research

People needed

615

Starts

2015-02-01

Expected to finish

2017-06-01

Last updated by the study team

2021-08-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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