EUS-FNA With 22G Procore Needles vs 22G Conventional Needles

NCT01581762 | Completed Phase 3 DMC

• 1 other identifier: ChineseUHK
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is an important investigation tool to obtain tissue for diagnosis. Nowadays, the performance of EUS-FNA varies with accuracy rates ranging from 60% - 100%. Needles with different diameters have been explored to retrieve tissue specimens. The diagnostic yields, successful rates and safety profiles are similar. It has been suggested that although thinner needles provide less cellular material than do larger needles, the specimens from the former are less contaminated by blood, and thus easier to interpret. In addition, thinner needles may be easier to use because of greater flexibility, particularly for locations requiring important scope bending. As a result, a new 22G FNA needle has been designed in order to improve the tissue-sampling rate (ECHO-HD-22-C, Cook Endoscopy, USA). There is a reverse bevel at the tip of the new needle with promotes collection of core sample by shearing material from target lesion during retrograde movement of the needle in the lesion. The feasibility and safety of this newly design EUS-FNA needle have been demonstrated in a recent multicenter, pooled, cohort study using the 19G version. Successful puncture was technically feasible in 98.2% of cases and the overall accuracy of 92.9%. There were no complications related to the technique. The aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy rate of EUS-FNA between the uses of the convention and newly designed 22-gauge needles.

Conditions

Self Efficacy

Keywords

EUS, FNA

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with cyto-histopathology confirmed neoplasms diagnosed by EUS-guided FNA

  A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is confirmed by surgical tissue samples when available or clinical follow-up after 1 year.

  1 year

Secondary Outcomes (1)

• Diagnostic accuracy

  1 year

Study Arms (2)

Conventional 22G Needle

SHAM COMPARATOR

Device: EUS-FNA with conventional 22G Needle

Procedure: EUS-guided FNA

22G Procore Needle

ACTIVE COMPARATOR

Device: EUS-FNA with 22G Procore Needle which has a reverse bevel at the tip of the needle to enhance tissue collection

Procedure: EUS-guided FNA

Interventions

EUS-guided FNA PROCEDURE

EUS-guided FNA with two types of needles - conventional 22G needle (Sham control) and Procore needle (active comparator)

Also known as: ECHO-HD-22-C, Cook Endoscopy, USA

22G Procore Needle; Conventional 22G Needle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages of 18-80 undergoing EUS-guided tissue acquisition
• Informed consent available

You may not qualify if:

• Coagulopathy
• Previous history of upper gastrointestinal surgery
• Contraindications for conscious sedation
• Pregnancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery

Hong Kong, Hong Kong

Location

Related Publications (11)

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  PMID: 21420083 BACKGROUND

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  PMID: 19179132 BACKGROUND

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  PMID: 11255521 BACKGROUND

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  PMID: 11275888 BACKGROUND

• Yusuf TE, Ho S, Pavey DA, Michael H, Gress FG. Retrospective analysis of the utility of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in pancreatic masses, using a 22-gauge or 25-gauge needle system: a multicenter experience. Endoscopy. 2009 May;41(5):445-8. doi: 10.1055/s-0029-1214643. Epub 2009 May 5.

  PMID: 19418399 BACKGROUND

• Itoi T, Itokawa F, Kurihara T, Sofuni A, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Kawai T, Moriyasu F. Experimental endoscopy: objective evaluation of EUS needles. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):509-16. doi: 10.1016/j.gie.2008.07.017.

  PMID: 19231491 BACKGROUND

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  PMID: 17427217 BACKGROUND

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  PMID: 17643700 BACKGROUND

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  PMID: 12094855 BACKGROUND

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  PMID: 14687813 BACKGROUND

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• CHARING C CHONG, MBChB

  Department of Surgery, CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 20, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

HK (1)