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Clinical Trials/NCT04403893
NCT04403893
Completed
Not Applicable

Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study

Istituto Clinico Humanitas1 site in 1 country20 target enrollmentJune 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Bilio-pancreatic Diseases
Sponsor
Istituto Clinico Humanitas
Enrollment
20
Locations
1
Primary Endpoint
AE and SAE events
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2020
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

AE and SAE events

Time Frame: 12 Months

To assess the technical safety for EUS-guided hepaticogastrostomy.

Study Sites (1)

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