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

October 11, 2016 updated by: Charing Chong, MD, Chinese University of Hong Kong

Prospective Comparative Study on Endoscopic Ultrasonography (EUS) - Guided Fine-Needle Aspiration (FNA) Using the 22G Conventional Needles or Procore Needles Without Immediate On-site Cytopathologic Examination

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic ultrasound (EUS) - guided fine needle aspiration (FNA) is a well-established technique for tissue sampling of intestinal and extra-intestinal mass lesions. The accuracy of EUS-guided FNA varies from 60% - 100% with a complication rate of 0% - 3%. The diagnostic accuracy of the procedure can be improved by the use immunohistochemical studies and genetic analyses.It may also be improved by obtaining a larger biopsy specimen with a core biopsy needle. However, puncturing with a core-biopsy needle may not be always feasible due to the technical difficulty of inserting the larger needle through the bended endoscope. As a result, the advantage of a core-biopsy needle on providing a larger amount of cellular material is offset by a higher rate of technical failures, especially in the setting of a transduodenal puncture. Recently, a new 22G FNA needle with a reverse bevel at the tip has become available (ECHO-HD-22-C, Cook Endoscopy, USA.). The design of the device promotes the collection of core samples by shearing material from target lesion during retrograde movement of the needle in the lesion. Hence, the aim of this study is to compare the tissue-sampling rate and the diagnostic accuracy rate of EUS-FNA using 22G conventional and Procore needles.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Conventional 22G Needle
Device: EUS-FNA with conventional 22G Needle
Procedure: EUS-guided FNA
EUS-guided FNA with two types of needles - conventional 22G needle (Sham control) and Procore needle (active comparator)
Other Names:
  • ECHO-HD-22-C, Cook Endoscopy, USA
Active Comparator: 22G Procore Needle
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
EUS-guided FNA with two types of needles - conventional 22G needle (Sham control) and Procore needle (active comparator)
Other Names:
  • ECHO-HD-22-C, Cook Endoscopy, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with cyto-histopathology confirmed neoplasms diagnosed by EUS-guided FNA
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: CHARING C CHONG, MBChB, Department of Surgery, CUHK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ChineseUHK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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