Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

Study Overview
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Brief Summary
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The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

Detailed Description
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There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency ( 3-9 months). Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.

Official Title
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Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

Conditions
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Hilar Cholangiocarcinoma

Intervention / Treatment
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* Device: biliary stent (self expandable metallic stent)
* Device: PS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP) Exclusion Criteria: Patients with ASA 4 or 5 Patients with liver failure. Patients unable to comply with follow-up

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 |
| --- | --- |
| Experimental: SEMS<br>self-expandable metal stent group | Device: biliary stent (self expandable metallic stent)<br>* metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP<br>* Other names: self expandable metallic stent;|
| Active Comparator: PS<br>plastic stent group | Device: PS<br>* plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP<br>* Other names: Amsterdam type plastic stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) | Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient. | at 2 weeks and 4 weeks after stent insertion | 
| Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis) | Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively. | at 2 weeks and 4 weeks after stent insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Survival Times | survival times of the patients after the first stent insertion | until patient died or 6 months after the last patient was enrolled | 
| Cost Effective Ratio of Metallic and Plastic Stent | cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature | until the patients expire (Markov model) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biliary stent, plastic stent, metallic stent, Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)