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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04403893
Other study ID # 2753
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 17, 2020
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HANARO biliary stent placement
HANARO biliary stent placement

Locations

Country Name City State
Italy Endoscopy Unit, Humanitas Research Hospital Rozzano Milano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary AE and SAE events To assess the technical safety for EUS-guided hepaticogastrostomy. 12 Months