FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions
Condition: Solid Lesions of the GI Tract or of Adjacent Organs
Study type: Interventional

Summary: 
      The intent of this study is to compare the performance of the CLA-EUS versus the FV-EUS in
      the performance of EUS-FNA of patients with solid lesions of the GI tract and of adjacent
      organs, with the aim of establishing for which lesions and from which location the capability
      of the FV-EUS will be superior, equal or, inferior to the CLA-EUS
    

Detailed description: 
      Recently, a forward viewing linear echoendoscope (FV-EUS) has been developed with the aim of
      potentially expanding the therapeutic applications of EUS. This prototype is a modification
      of the CLA scope and it is characterized primarily by a shifting of the orientation of the
      endoscopic and US views from oblique to forward. The US transducer is located adjacent to the
      working channel, at the endoscope tip, to display a forward-viewing image along to a scanning
      plane that is parallel to the insertion direction with a 90° scanning range. It has a 3.7 mm
      working channel without elevator, which allows exit of the FNA needle or any other accessory
      used parallel to the longitudinal axis of the scope.

      Preliminary experiences with this scope have reported potential advantages over the
      conventional linear scope (CLA-EUS) for pseudocysts drainage and for hilar biliary
      strictures. Moreover, a large experience still unpublished from the Catholic University,
      Rome, Italy in the use of the FV-EUS for FNA of solid and cystic lesions throughout the GI
      tract has shown the FV-EUS to be highly effective with a performance that seems at least
      comparable to that of the CLA-EUS. To date, however, no data comparing the performance of
      both scopes for FNA of target lesions are available to better clarify the advantages and
      disadvantages of one scope over the other.

      We designed a randomized comparative trial in which patients will be randomized to undergo
      examination with CLA-EUS or with FV-EUS. In case of failure of: (i) visualization of the
      presumed lesion; (ii) failure in performing the FNA with the scope used based on
      randomization, a second attempt will be made using the other scope.
    

Intervention name(s): EUS-guided fine needle aspiration
Intervention type(s): Device
Intervention description(s): Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: EUS-FNA, Forward viewing EUS scope, Curvilinear EUS scope