25G FNA needle
DeviceOther names: 25G Echotip Ultra Fine Needle Aspiration (FNA) device
NCT Number: NCT02167074
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.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
The Royal Adelaide Hospital, Adelaide, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: 25G Echotip Ultra Fine Needle Aspiration (FNA) device
Other names: 20G Echotip ProCore Fine Needle Biopsy (FNB) device
Time frame: 27 months
Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis
Gold standard diagnosis is defined as;
Time frame: 1 day
records if a target lesion was reached during the procedure using the randomised needle or not
Time frame: after 27 months
Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
Time frame: 27 months after procedure
adverse events per needle type, up to 27 months after procedure
Time frame: after 27 months
Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not
Time frame: 27 months
Presence of pathologist on site during procedure
Foundation for Liver Research
Other
A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device
Acronym: ASPRO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06724055
Pancreatic Masses
View Trial DetailsNCT02946840
Pancreatic Masses
Rozzano, Milano, Italy
View Trial DetailsNCT01576497
Pancreatic Masses
Seoul, South Korea
View Trial DetailsNCT01016288
Adrenal Masses, Celiac Disease
Copenhagen, Denmark
View Trial Details