Covered or Uncovered Bile Duct Stents

Study Overview
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Brief Summary
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The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents. These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications. The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

Detailed Description
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0

Official Title
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Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.

Conditions
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Bile Duct Neoplasms

Intervention / Treatment
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* Device: covered or uncovered stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unresectable, distal bile duct stricture needing relieved endoscopically Expected survival greater than 3 months The patient must give written consent to participate in the study Exclusion Criteria: Stricture close to hilus Need for interpreter
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: covered self expandable metallic stents<br>Patients with bile malignant bile duct strictures are randomized to covered or uncovered stent | Device: covered or uncovered stents<br>* Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.<br>* Other names: Bile duct neoplasms;|
| Active Comparator: Uncovered self expandable metallic stent<br> | Device: covered or uncovered stents<br>* Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.<br>* Other names: Bile duct neoplasms;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS |  | Stent occlusion or patient death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents |  | Evaluated within three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covered, uncovered, palliative treatment, stent