A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device
Phase: NA
Conditions: Pancreatic Masses, Lymph Nodes
Sponsor: Foundation for Liver Research

 
Study protocol 
 
 
A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle 
Aspiration (FNA) Device with a 20G EUS ProCore Fine Needle 
Biopsy (FNB) Device  
 
 
ASPRO trial (ASPiration versus PROcore) 
 
 
 
ProCore study group 
 
 
 

PROTOCOL TITLE  
Protocol ID 
ASPRO trial 
Short title 
Comparing a 25G EUS-FNA with a 20G EUS ProCore 
FNB Device 
Version 
Version 1 
Date 
13-10-2014 
Coordinating investigator 
 
Drs P.A. van Riet 
Department of Gastroenterology & Hepatology, 
Room Ca-415, Erasmus University Medical Center, 
Rotterdam, the Netherlands 
Email; p.vanriet@erasmusmc.nl 
Principal investigator  
 
 (See paragraph 3.1 for a list of all 
principal investigators per site) 
 
 
Dr D.L. Cahen 
Department of Gastroenterology & Hepatology, 
Room H-337, Erasmus University Medical Center, 
Rotterdam, the Netherlands 
Email; djuna@cahen.nl 
Sponsor 
SLO (in Dutch: Stichting Lever Onderzoek, in English: 
Foundation for Liver and Gastrointestinal Research)       
on behalf of the Department of Gastroenterology and 
Hepatology of the Erasmus University Medical Center in 
Rotterdam, the Netherlands 
Subsidising party of  
unrestricted grant 
Cook Medical 
O'Halloran Road 
National Technology Park 
Limerick, Ireland 
www.cookmedical.com 
 
Independent physician 
Dr D. Sprengers 
Department of Gastroenterology & Hepatology, Erasmus 
University Medical Center, Rotterdam, the Netherlands 
Email; d.sprengers@erasmusmc.nl 
 

Laboratory sites 
Department of Clinical Pathology, Erasmus University 
Medical Center, Rotterdam, the Netherlands 
Pharmacy 
Not applicable 
 
SUMMARY 
Rationale: During Endoscopic Ultrasound (EUS), tissue samples can be obtained with different 
techniques. Fine needle aspiration (FNA) provides a cytological specimen. With fine needle biopsy 
(FNB), a histological specimen is obtained, which generally results in a better diagnostic performance. 
However, FNB needles are stiffer and more difficult to handle, and can therefore result in less tissue 
acquisition.  
Objectives: To compare the performance and diagnostic accuracy of two EUS-guided tissue 
acquisition devices; a 25G Echotip Ultra Fine Needle Aspiration (FNA) device and a new, more 
flexible 20G Echotip ProCore Fine Needle Biopsy (FNB) device. 
Study design:  International randomized multicenter trial. 
Study population: Patients ≥18 years old, referred for EUS-guided tissue sampling of a: (I) 
pancreatic mass lesion, (II) lymph node, or (III) other submucosal or undefined mass (non-pancreatic), 
≥ 1 cm in size. 
Intervention: EUS-guided tissue acquisition by means of either the 25G Echotip Ultra FNA device, 
or the 20G Echotip ProCore FNB device. 
Main study parameters/endpoints: The main endpoint is the diagnostic performance, measured 
against the gold standard diagnosis (based on the surgical resection specimen or in non-operated 
patients, the outcome of the diagnostic work-up (i.e. tissue sampling and imaging studies), confirmed 
by a compatible clinical disease course). Secondary endpoints include I. technical success, II, specimen 
specifics, such as; quality, presence of tissue cores, and pathological classification (cytology, cell-block, 
or histology), III. procedural aspects, such as; safety, the yield of a single needle pass, and the value of 
on-site pathological evaluation, and IV. inter-observer variation. 
Nature and extent of the burden and risks associated with participation, benefit and 
group relatedness: There are no additional risks involved. Patients are referred for EUS-guided 
tissue acquisition, as part of the standard diagnostic work-up. Previous reports showed EUS-guided 
FNA and FNB sampling to be equally safe.