Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction

Study Overview
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Brief Summary
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Purpose of the study -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction Subjects of the study -Patients who have biliary obstruction owing to malignant tumors Methods of the study Prospective randomized controlled study Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.

Detailed Description
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Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction

Official Title
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Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction

Conditions
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Tumor Appearance of Biliary System Obstruction

Intervention / Treatment
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* Procedure: ERCP-guided stent insertion
* Procedure: EUS guided stent insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: distal biliary obstruction due to malignant tumor unresectable tumor Jaundice Exclusion Criteria: Children Hilar obstruction Active infection Bleeding tendency

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERCP guided stent insertion<br> | Procedure: ERCP-guided stent insertion<br>* ERCP guided stent insertion for malignant biliary obstruction<br>* Other names: ERCP-guided metal stent insertion;|
| Active Comparator: EUS guided stent insertion<br> | Procedure: EUS guided stent insertion<br>* EUS-guided stent insertion for malignant biliary obstruction<br>* Other names: EUS-guided metal stent insertion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent patency (days) |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent patency, EUS guided insertion, ERCP guided insertion