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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Charing Chong, MD, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01581762
First received: April 16, 2012
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Self Efficacy
Procedure: EUS-guided FNA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Proportion of patients with cyto-histopathology confirmed neoplasms diagnosed by EUS-guided FNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Diagnostic accuracy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 152
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: ECHO-HD-22-C, Cook Endoscopy, USA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581762

Locations
Hong Kong
Department of Surgery
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: CHARING C CHONG, MBChB Department of Surgery, CUHK
  More Information

Publications:

Responsible Party: Charing Chong, MD, Doctor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01581762     History of Changes
Other Study ID Numbers: ChineseUHK
Study First Received: April 16, 2012
Last Updated: January 19, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
EUS, FNA

ClinicalTrials.gov processed this record on April 16, 2014