A Multicenter Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS 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.

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