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

Foundation for Liver Research

Status: Completed

Conditions: Lymph Nodes; Pancreatic Masses

Treatments: Device: 25G FNA needle; Device: 20G ProCore FNB needle

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02167074

ASPRO-2014-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 615 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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615 participants in 2 patient groups

25G FNA needle

Active Comparator group

Description:

Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).

Treatment:

Device: 25G FNA needle

20G ProCore FNB needle

Active Comparator group

Description:

Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).

Treatment:

Device: 20G ProCore FNB needle