Solid Lesions of the GI Tract or of Adjacent Organs Clinical Trial
Official title:
Forward Viewing US Endoscope Versus Standard Viewing US Endoscope in the Performance of EUS-guided Fine Needle Aspiration of Solid Lesions of the Gastrointestinal Tract and of Adjacent Organs: A Prospective Randomized Controlled Study
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
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 Moreover, a large experience still unpublished from the Catholic University,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.
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