Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

Study Overview
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Brief Summary
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The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.

Detailed Description
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In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.

Official Title
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Comparison of Metal Versus Plastic Side-by-side Stent Insertion in Malignant Hilar Biliary Obstruction

Conditions
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Malignant Hepatobiliary Neoplasm

Intervention / Treatment
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* Procedure: endoscopic retrograde cholangio-pancreatography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure Exclusion Criteria: If endoscopy is not possible based on the judgement of the researcher Life expectancy less than 6 months Acute cholecystitis Previous history of percutaneous transhepatic biliary drainage Previous history of metal stent placement for malignant biliary stricture

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: FCSEMS<br>In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In FCSEMS group, patients are inserted with Fully covered self-expandable metal stent (FCSEMS) bilaterally for malignant hilar biliary stricture via endoscopic retrograde cholangio-pancreatography. | Procedure: endoscopic retrograde cholangio-pancreatography<br>* In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.<br>* Other names: FCSEMS;|
| Active Comparator: Plastic stent<br>In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In plastic stent group, patients are inserted with plastic stents bilaterally for malignant hilar biliary stricture. | Procedure: endoscopic retrograde cholangio-pancreatography<br>* In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.<br>* Other names: FCSEMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of stent patency | The period from the insertion of the stent to the point at which stent revision is required. | 9 months after randomization. |