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

Lymph Nodes Clinical Trial

— ASPRO  

Official title:

A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167074
• Other study ID #: ASPRO-2014-01
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: August 2021
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

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

Related Conditions & MeSH terms

• Lymph Nodes
• Pancreatic Masses

Intervention

Device:
• 25G FNA needle

• 20G ProCore FNB needle

Locations

Country	Name	City	State
Australia	The Royal Adelaide Hospital	Adelaide
Belgium	University Hospital Leuven	Leuven
France	Institut Paoli-Calmettes	Marseille
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Vita Salute San Raffaele University	Milan
Italy	Catholic University Rome	Rome
Japan	Kinki University	Osaka-sayama
Netherlands	Erasmus University Medical Center	Rotterdam	Zuid-Holland
Spain	University Hospital of Santiago de Compostella	Santiago De Compostela
Sweden	Karolinska University Hospital	Stockholm
United States	University of California	Irvine	California
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Stony Brook University Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Liver Research	Cook Ireland, Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Israel,  Italy,  Japan,  Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy	Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis; Gold standard diagnosis is defined as; in operated patients; based on the surgical resection specimen; 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	27 months
Secondary	Number of Participants in Whom Target Lesion Was Sampled	records if a target lesion was reached during the procedure using the randomised needle or not	1 day
Secondary	Presence of Vital Target Cells Per Case, Per Needle Type	Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)	after 27 months
Secondary	Number of Patients With Adverse Events Per Needle Type	adverse events per needle type, up to 27 months after procedure	27 months after procedure
Secondary	Diagnostic Yield of the First Needle Pass	Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not	after 27 months
Secondary	On-site Pathological Evaluation Performed	Presence of pathologist on site during procedure	27 months