Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study
Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study
One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative
 to ERCP-based biliary decompression.

 In fact, even when performed by expert endoscopists, ERCP-based stenting fails in 5% of
 cases. In these cases, standard alternative approaches include surgical bypass and
 percutaneous transhepatic cholangiography and biliary drainage (PTBD). However, these
 procedures are associated with higher patient discomfort and prolonged hospital stay.

 The most diffuse approach for EUS-BD are choledochoduodenostomy (CDS) or hepaticogastrostomy
 (HGS). As a matter of fact, since dedicate devices as lumen apposing metal stents (LAMS),
 have been adopted for CDS, we have been witnessing the escalation of such procedure.

 On the other hand, the diffusion of EUS-HGS is still limited due to the complexity of the
 procedure and the lack of dedicated devices. However, recently a dedicated stent was
 conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end
 into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce
 the risk of migration. The developement of such stent could further increase both the
 technical feasibility and the clinical outcomes of HGS in order to explore the whole
 potential of this procedure and to definitively find its role in biliary drainage algorithm.
Inclusion Criteria:

 • subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary
 stent positioning for biliary drainage after ERCP failure.

 Exclusion Criteria:

 -  Age < 18 y

 -  Contra-indication for endoscopy or interventional radiology

 -  Unsigned informing consent form, ICF

 -  Pregnancy