FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions
FV-EUS Endoscope Versus CLA-EUS for EUS-FNA of Solid Lesions
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 Moreover, a large experience still unpublished from the Catholic University,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.
Inclusion Criteria:

 1. Presence of a solid lesion in the GI tract or in one of the adjacent organs identified
 at abdominal US, CT, MRI/MRCP that needs to be samples with EUS-FNA because
 unresectable or because tissue characterization is needed to decide further treatment
 modalities

 2. Age greater than 18.

 3. Absence of histological or cytological confirmation of malignancy.

 4. Informed consent obtained.

 Exclusion Criteria:

 1. Patients with active coagulopathy that cannot be corrected after administration of
 plasma.

 2. Resectable lesions that does not need tissue characterization to decide treatment
 modalities.

 3. Pregnancy.

 4. Patients who cannot give inform consent.