A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent

Study Overview
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Brief Summary
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Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction

Detailed Description
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This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.

Official Title
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A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study

Conditions
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Malignant Biliary Obstruction

Intervention / Treatment
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* Device: fully covered self-expandable metal stent with an anchoring external plastic stent
* Device: uncovered self-expandable metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with 19 years of age or older Those who voluntarily consented to the trial and signed a written consent Inoperable malignant biliary obstruction Exclusion Criteria: Previous surgical biliary drainage Patients continuosly requiring percutaneous transhepatic biliary drainage History of biliary drainage with metal stent Biliary obstruction located in hilum or intrahepatic duct Patients with life expectancy of 3 months or less On pregnancy Unable to underwent endoscopic procedures

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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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: fc-SEMS with anchoring plastic stent<br>fully covered self-expanable metal stent with an external anchoring plastic stent | Device: fully covered self-expandable metal stent with an anchoring external plastic stent<br>* Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent<br>|
| Active Comparator: uc-SEMS<br>uncovered self-expandable metal stent | Device: uncovered self-expandable metal stent<br>* Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patent stent | The number of patient without stent dysfuction divided by total number of patients | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent obstruction | Suspected by jaundice (Total bilirubin > 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP | 1 year | 
| Stent migration | Radiologic finding of migration through Abdomen X-ray or CT scan | 1 year | 
| Re-intervention | Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage | 1 year | 
| Adverse event | acute cholangitis, acute cholecystitis, acute pancreatitis | 1 year | 
| Overall survival | Timespan from the diagnosis to the death | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fully Covered Self Expandable Metal Stent, Uncovered Self Expandable Metal Stent