EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

Study Overview
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Brief Summary
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EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety. The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.

Detailed Description
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This is a prospective feasibility study enrolling patients suffering from malignant biliary obstruction with failed or anticipated difficult ERCP. Consecutive patients satisfying the inclusion criteria would be recruited. EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent. The MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) is a novel device designed for hepaticogastrostomy. The stent is a partially covered metal stent made by nitinol covered with silicone. One end of the stent is uncovered and designed for placement in the intrahepatic ducts. The other end has a self-folding design that creates a flange and prevents migration of the stent outside the stomach. The stent diameter is either 8 or 10mm and the length can be 6,8,10 or 12cm long. Outcome parameters include safety, technical and clinical success

Official Title
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EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent

Conditions
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Malignant Biliary Obstruction

Intervention / Treatment
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* Device: EUS-guided hepaticogastrostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 years of age Anatomically feasible for EUS-guided hepatico-gastrostomy Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis) Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis) Written informed consent (and assent when applicable) obtained from subject. Exclusion Criteria: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Coagulopathic patients (INR>1.5, platelets <50,000)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-guided hepaticogastrostomy<br>EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea). | Device: EUS-guided hepaticogastrostomy<br>* EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | a life-threatening or severe event requiring endoscopic and/or surgical intervention, transfusion or IV/IM antibiotics | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with technical success | transmural placement of the stent across the stomach or duodenum into the bile duct | 1 day | 
| Number of patients with Clinical success | decrease of >20% bilirubin from baseline level | 7 days | 
| Stent patency | the period between stent insertion and stent occlusion or stent removal | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant Biliary Obstruction, EUS-biliary drainage, EUS-guided hepaticogastrostomy