Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

Study Overview
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Brief Summary
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The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months. There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction. The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.

Official Title
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Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial

Conditions
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Bile Duct Obstruction, Klatskin's Tumor

Intervention / Treatment
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* Device: SEMS insertion
* Device: DLS insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years old Patient with malignant hilar obstruction Exclusion Criteria: No written informed consent Patient with uncorrectable severe coagulopathy Indication for surgical operation Karnofsky score < 60%

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 |
| --- | --- |
| Active Comparator: SEMS<br>Self-expandable metallic stent will be inserted for the malignant hilar obstruction. | Device: SEMS insertion<br>* Self-expandable metallic stent will be inserted for malignant hilar obstruction.<br>* Other names: TaeWoong stent;|
| Active Comparator: DLS<br>DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction. | Device: DLS insertion<br>* DoubleLayer plastic stent will be inserted for malignant hilar obstruction.<br>* Other names: Olympus DoubleLayer stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent patency | Interval time (d) from stent insertion to occlusion | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause complications | Early or Late complications asymptomatic hyperamylasemia pancreatitis (mild/moderate/severe) cholecystitis cholangitis recurrent jaundice Internal migration external migration occlusion | Up to 2 years | 
| Cost-effectiveness | Total Cost for SEMS and DLS group ERCP cost Total ERBD cost (DLS or metal) Total hospitalization cost Cost for session x No. of session Total (DLS vs. metal)cost /session | Up to 2 years | 
| Mortality |  | Up to 2 years | 
| Technical success | Successful insertion of bilateral or unilateral stent insertion. Time to adequate expansion (70% of maximal expanded diameter was dilated state) in metal stent ≤ 24 hrs No stent migration within 24 hrs | within 24 hr after stent insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant hilar stricture