Partially Covered and Uncovered Metal Stent for Malignant Distal Biliary Stricture

Study Overview
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Brief Summary
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Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. With potentially curative surgical resection being impossible, the maintenance of successful biliary drainage through patent stent has been regarded as the key to improve the quality of life and survival of patient, because it could prevent biliary infection or liver failure, and give patients opportunities for anti-cancer chemotherapy and/or radiotherapy. Although SEMSs have been reported to be superior to large bore plastic stents in terms of stent patency, they still have some controversial issues to resolve in relation to stent dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs, despite some clinical results of randomized trials favor to covered SEMSs. From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting results have been produced. It was initially assumed that covered SEMSs could cause the higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct and cystic duct by covering materials. However, no significant difference was found with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs in several randomized trials and meta-analysis. The aim of the current study is to compare the cumulative stent patency of partially covered and uncovered SEMS as a primary objective, and investigate overall patient survival, stent dysfunction-free patient survival, and incidence of adverse events including stent dysfunction as secondary objectives.

Official Title
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A Randomized Trial of Partially Covered Versus Uncovered Self Expandable Metal Stents for the Palliation of Malignant Distal Biliary Stricture

Conditions
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Malignant Distal Biliary Stricture

Intervention / Treatment
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* Device: Deployment of Partially covered biliary self expandable metal stent
* Device: Deployment of uncovered biliary self expandable metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 20 years malignant biliary obstruction, 2 cm distal to hilum unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal expected survival > 4 months based on Karnofsky performance score. Exclusion Criteria: history of biliary surgery except cholecystectomy history of SEMS placement coagulopathy (INR>1.5, Platelet<50000) duodenal stricture

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Partially covered biliary self expandable metal stent<br> | Device: Deployment of Partially covered biliary self expandable metal stent<br> <br> |
| Active Comparator: Uncovered biliary self expandable metal stent<br> | Device: Deployment of uncovered biliary self expandable metal stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative stent patency |  | From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patient survival |  | From the date of randomization until the date of death from any cause, assessed upto 12 months | 
| Stent dysfunction free-patient survival |  | From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 12 months |