EUS-FNA With 22G Procore Needles vs 22G Conventional Needles
Condition: Self Efficacy
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): EUS-guided FNA
Intervention type(s): Procedure
Intervention description(s): EUS-guided FNA with two types of needles - conventional 22G needle (Sham control) and Procore needle (active comparator)
Other intervention name(s): ECHO-HD-22-C, Cook Endoscopy, USA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EUS, FNA