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

Foundation for Liver Research615 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

615

Conditions

Pancreatic Masses Lymph Nodes

Interventions

25G FNA needleDEVICE

20G ProCore FNB needleDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (13)

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

Outcomes

Primary Outcomes

Diagnostic Accuracy

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

Time frame: 27 months

Secondary Outcomes

Number of Participants in Whom Target Lesion Was Sampled

records if a target lesion was reached during the procedure using the randomised needle or not

Time frame: 1 day

Presence of Vital Target Cells Per Case, Per Needle Type

Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)

Time frame: after 27 months

Number of Patients With Adverse Events Per Needle Type

adverse events per needle type, up to 27 months after procedure

Time frame: 27 months after procedure

Diagnostic Yield of the First Needle Pass

Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not

Time frame: after 27 months

On-site Pathological Evaluation Performed

Presence of pathologist on site during procedure

Time frame: 27 months

Data from ClinicalTrials.gov

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