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

NCT ID: NCT02167074

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 615 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-06-01

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.

Conditions

Pancreatic Masses; Lymph Nodes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

25G FNA needle

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

Group Type: ACTIVE_COMPARATOR

25G FNA needle

Intervention Type: DEVICE

20G ProCore FNB needle

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

Group Type: ACTIVE_COMPARATOR

20G ProCore FNB needle

Intervention Type: DEVICE

Interventions

25G FNA needle

Intervention Type: DEVICE

20G ProCore FNB needle

Intervention Type: DEVICE

Other Intervention Names

25G Echotip Ultra Fine Needle Aspiration (FNA) device; 20G Echotip ProCore Fine Needle Biopsy (FNB) 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook Ireland, Ltd.

INDUSTRY

Sponsor Role: collaborator

Foundation for Liver Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco J Bruno, MD, PhD

Role: STUDY_CHAIR

Erasmus Medical Center

Djuna L Cahen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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, United States

The Royal Adelaide Hospital

Adelaide, , Australia

University Hospital Leuven

Leuven, , Belgium

Institut Paoli-Calmettes

Marseille, , France

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Vita Salute San Raffaele University

Milan, , Italy

Catholic University Rome

Rome, , Italy

Kinki University

Ōsaka-sayama, , Japan

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

University Hospital of Santiago de Compostella

Santiago de Compostela, , Spain

Karolinska University Hospital

Stockholm, , Sweden

Countries

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

References

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.

Reference Type: DERIVED

PMID: 31330556 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30367877 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ASPRO-2014-01

Identifier Type: -

Identifier Source: org_study_id