Clinical trial NCT02167074: Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Masses
Lymph Nodes
Keywords: Diagnostic accuracy
Endoscopic Ultrasound-Guided Fine Needle Aspiration
EUS-FNA
Endoscopic Ultrasound-Guided Fine Needle Biopsy
EUS-FNB
Pancreatic mass
Lymph node
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
Collaborators: name: Cook Ireland, Ltd.
First posted: 2014-06-18
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: 27 months
Secondary outcomes:
measure: Number of Participants in Whom Target Lesion Was Sampled
timeFrame: 1 day
measure: Presence of Vital Target Cells Per Case, Per Needle Type
timeFrame: after 27 months
measure: Number of Patients With Adverse Events Per Needle Type
timeFrame: 27 months after procedure
measure: Diagnostic Yield of the First Needle Pass
timeFrame: after 27 months
measure: On-site Pathological Evaluation Performed
timeFrame: 27 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: New York
country: United States
facility: Stony Brook University Hospital
state: New York
city: Adelaide
country: Australia
facility: The Royal Adelaide Hospital
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Milan
country: Italy
facility: Vita Salute San Raffaele University
city: Rome
country: Italy
facility: Catholic University Rome
city: Osaka-sayama
country: Japan
facility: Kinki University
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid-Holland
city: Santiago De Compostela
country: Spain
facility: University Hospital of Santiago de Compostella
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Marco J Bruno, MD, PhD
role: STUDY_CHAIR
affiliation: Erasmus Medical Center
name: Djuna L Cahen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Riet PA, Giorgio Arcidiacono P, Petrone M, Quoc Nguyen N, Kitano M, Chang K, Larghi A, Iglesias-Garcia J, Giovannini M, van der Merwe S, Santo E, Baldaque-Silva F, Bucobo JC, Bruno MJ, Aslanian HR, Cahen DL, Farrell J. Combined versus single use 20 G fine-needle biopsy and 25 G fine-needle aspiration for endoscopic ultrasound-guided tissue sampling of solid gastrointestinal lesions. Endoscopy. 2020 Jan;52(1):37-44. doi: 10.1055/a-0966-8755. Epub 2019 Jul 22.
citation: van Riet PA, Larghi A, Attili F, Rindi G, Nguyen NQ, Ruszkiewicz A, Kitano M, Chikugo T, Aslanian H, Farrell J, Robert M, Adeniran A, Van Der Merwe S, Roskams T, Chang K, Lin F, Lee JG, Arcidiacono PG, Petrone M, Doglioni C, Iglesias-Garcia J, Abdulkader I, Giovannini M, Bories E, Poizat F, Santo E, Scapa E, Marmor S, Bucobo JC, Buscaglia JM, Heimann A, Wu M, Baldaque-Silva F, Moro CF, Erler NS, Biermann K, Poley JW, Cahen DL, Bruno MJ. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointest Endosc. 2019 Feb;89(2):329-339. doi: 10.1016/j.gie.2018.10.026. Epub 2018 Oct 24.