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

NCT02167074 | Completed Results

• 1 other identifier: ASPRO-2014-01
• Study Type: interventional
• Target: 615
• Locations: 10 countries
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  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

  27 months

Secondary Outcomes (5)

• Number of Participants in Whom Target Lesion Was Sampled

  1 day

• Presence of Vital Target Cells Per Case, Per Needle Type

  after 27 months

• Number of Patients With Adverse Events Per Needle Type

  27 months after procedure

• Diagnostic Yield of the First Needle Pass

  after 27 months

• On-site Pathological Evaluation Performed

  27 months

Study Arms (2)

25G FNA needle

ACTIVE COMPARATOR

Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).

Device: 25G FNA needle

20G ProCore FNB needle

ACTIVE COMPARATOR

Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).

Device: 20G ProCore FNB needle

Interventions

25G FNA needle DEVICE

Also known as: 25G Echotip Ultra Fine Needle Aspiration (FNA) device

25G FNA needle

20G ProCore FNB needle DEVICE

Also known as: 20G Echotip ProCore Fine Needle Biopsy (FNB) device

20G ProCore FNB needle

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Foundation for Liver Research: lead
• Cook Ireland, Ltd.: collaborator

Study Sites (13)

University of California

Irvine, California, CA 92868, United States

Location

Yale University School of Medicine

New Haven, Connecticut, CT 06520, United States

Location

Stony Brook University Hospital

New York, New York, NY 11794, United States

Location

The Royal Adelaide Hospital

Adelaide, Australia

Location

University Hospital Leuven

Leuven, Belgium

Location

Institut Paoli-Calmettes

Marseille, France

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Vita Salute San Raffaele University

Milan, Italy

Location

Catholic University Rome

Rome, Italy

Location

Kinki University

Ōsaka-sayama, Japan

Location

Erasmus University Medical Center

Rotterdam, South Holland, 3015 CE, Netherlands

Location

University Hospital of Santiago de Compostella

Santiago de Compostela, Spain

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

• 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.

  PMID: 31330556 DERIVED

• 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.

  PMID: 30367877 DERIVED

Results Point of Contact

• Title: Dr. P. van Riet
• Organization: Erasmusm MC University Medical Center Rotterdam

p.vanriet@erasmusmc.nl

0031648237608

Study Officials

• Marco J Bruno, MD, PhD

  Erasmus Medical Center

  STUDY CHAIR

• Djuna L Cahen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 18, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 23, 2021
• Results First Posted: March 25, 2020

Record last verified: 2021-08

Locations

US (3); ES (1); SE (1); AU (1); BE (1); JP (1); IL (1); IT (2); FR (1); NL (1)