Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction

Study Overview
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Brief Summary
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The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.

Detailed Description
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Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration. The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.

Official Title
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Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction

Conditions
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Biliary Tract Neoplasms

Intervention / Treatment
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* Device: partially covered SEMS
* Device: fully covered SEMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal Exclusion Criteria: 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR>1.5, Platelet<50000) 4.expected survival > 3 months based on Karnofsky performance score 5.duodenal 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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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 |
| --- | --- |
| Active Comparator: partially covered SEMS<br>Deployment of Partially covered biliary self expandable metal stent | Device: partially covered SEMS<br>* Used for palliation of inoperable malignant distal bile duct obstruction.<br>* Other names: Insertion of partially covered SEMS (PCSEMS);|
| Active Comparator: fully covered SEMS<br>Deployment of Fully covered biliary self expandable metal stent | Device: fully covered SEMS<br>* Used for palliation of inoperable malignant distal bile duct obstruction.<br>* Other names: Insertion of fully covered SEMS (FCSEMS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of 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 survival |  | From the date of randomization until the date of death from any cause, assessed upto 12 months | 
| stent occlusion rate |  | From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months | 
| stent related complication |  | From the date of randomization until the date of first documented stent related complication, assessed up to 12 months |