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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
25G FNA needle	25G FNA needle	Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).
20G ProCore FNB needle	20G ProCore FNB needle	Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	27 months	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

Secondary Outcome Measures

Name	Time	Method
Presence of Vital Target Cells Per Case, Per Needle Type	after 27 months	Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
Number of Patients With Adverse Events Per Needle Type	27 months after procedure	adverse events per needle type, up to 27 months after procedure
Number of Participants in Whom Target Lesion Was Sampled	1 day	records if a target lesion was reached during the procedure using the randomised needle or not
On-site Pathological Evaluation Performed	27 months	Presence of pathologist on site during procedure
Diagnostic Yield of the First Needle Pass	after 27 months	Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not

Locations (13): Institut Paoli-Calmettes
🇫🇷
Marseille, France
Tel Aviv Sourasky Medical Center
🇮🇱
Tel Aviv, Israel
Vita Salute San Raffaele University
🇮🇹
Milan, Italy
Stony Brook University Hospital
🇺🇸
New York, New York, United States
The Royal Adelaide Hospital
🇦🇺
Adelaide, Australia
University Hospital Leuven
🇧🇪
Leuven, Belgium
University Hospital of Santiago de Compostella
🇪🇸
Santiago De Compostela, Spain
Catholic University Rome
🇮🇹
Rome, Italy
Karolinska University Hospital
🇸🇪
Stockholm, Sweden
Kinki University
🇯🇵
Osaka-sayama, Japan
Erasmus University Medical Center
🇳🇱
Rotterdam, Zuid-Holland, Netherlands
University of California
🇺🇸
Irvine, California, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States