Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent

Study Overview
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Brief Summary
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Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy. Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents. There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent. Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent

Official Title
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Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent

Conditions
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Obstruction of Biliary Tree, Cholangiocarcinoma, Hepatocellular Carcinoma, Malignant Lymphadenopathy, Gall Bladder Cancer

Intervention / Treatment
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* Device: stent insertion
* Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 diagnosis of malignancy in pathology or cytology jaundice(Total bilirubin)> 2.0 mg/dL Diagnosed malignant hilar invasion to CT or other image finding Exclusion Criteria: bleeding tendency(INR>1.5) Pregnancy severe liver,kidney disease

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unilateral stent insertion group<br>the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) | Device: stent insertion<br>* to use a LCD stent at an unilateral or bilateral stent insertion<br>* Other names: Niti-S large cell D-type biliary stent [LCD];Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)<br>* to use ERCP for a stent insertion in an obstructive biliary tract<br>|
| Active Comparator: Bilateral stent insertion group<br>the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) | Device: stent insertion<br>* to use a LCD stent at an unilateral or bilateral stent insertion<br>* Other names: Niti-S large cell D-type biliary stent [LCD];Procedure: Endoscopic retrograde cholangiopancreatoscopy(ERCP)<br>* to use ERCP for a stent insertion in an obstructive biliary tract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent patency | Participants will followed for the new obstruction(new jaundice) will occur. | up to 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival period | Participants will followed for 1year. | up to 1year |