Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04403893
Acronym
FIT
Enrollment
20
Registered
2020-05-27
Start date
2020-06-17
Completion date
2021-12-31
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Bilio-pancreatic Diseases

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.

Interventions

OTHERHANARO biliary stent placement

HANARO biliary stent placement

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AE and SAE events12 MonthsTo assess the technical safety for EUS-guided hepaticogastrostomy.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026