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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

April 16, 2012
January 19, 2014
April 2012
April 2014   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01581762 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
EUS-FNA With 22G Procore Needles vs 22G Conventional Needles
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Self Efficacy
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
  • Sham Comparator: Conventional 22G Needle
    Device: EUS-FNA with conventional 22G Needle
    Intervention: Procedure: EUS-guided FNA
  • 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
    Intervention: Procedure: EUS-guided FNA

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
152
October 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01581762
ChineseUHK
Yes
Charing Chong, MD, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: CHARING C CHONG, MBChB Department of Surgery, CUHK
Chinese University of Hong Kong
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP