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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Masses, Lymph Nodes

Intervention / Treatment
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* Device: 25G FNA needle
* Device: 20G ProCore FNB needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 25G FNA needle<br>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<br> <br> * Other names: 25G Echotip Ultra Fine Needle Aspiration (FNA) device;|
| Active Comparator: 20G ProCore FNB needle<br>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<br> <br> * Other names: 20G Echotip ProCore Fine Needle Biopsy (FNB) device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy | 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 | 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | after 27 months | 
| Number of Patients With Adverse Events Per Needle Type | adverse events per needle type, up to 27 months after procedure | 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 | after 27 months | 
| On-site Pathological Evaluation Performed | Presence of pathologist on site during procedure | 27 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic accuracy, Endoscopic Ultrasound-Guided Fine Needle Aspiration, EUS-FNA, Endoscopic Ultrasound-Guided Fine Needle Biopsy, EUS-FNB, Pancreatic mass, Lymph node