Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

Study Overview
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Brief Summary
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Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Self expanding metallic stents (SEMS) have a longer duration of patency and fewer of recurrence occlusion of stent when compared with plastic stent (PS). However, the cost of MS is more expensive than PS about 4 times. Therefore, many patients cannot afford the MS due to their economic status. Data regarding the efficacy and safety of multiple PS compared with single PS for the palliative treatment in unresectable malignant distal bile duct obstruction are limited.

Detailed Description
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The aim of the current study is to compare the cumulative stent patency of multiple PS and single plastic stent and the clinical success rate as a primary objective, investigate the technical success rate, procedure time incident of overall adverse events including stent dysfunction and overall procedure related mortality as secondary outcomes.

Official Title
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A Prospective Randomized Trial Comparing Single Plastic Stent Versus Multiple Plastic Stents in Inoperable Malignant Distal Bile Duct Obstruction.

Conditions
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Plastic Stent Occlusion

Intervention / Treatment
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* Device: Single plastic stent
* Device: Multiple plastic stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In-operable distal malignant bile duct obstruction Age>18 Exclusion Criteria: Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP

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: Single plastic stent<br>Deployment of single plastic stent | Device: Single plastic stent<br>* Deployment of single plastic stent<br>|
| Active Comparator: Multiple plastic stents<br>Deployment of multiple plastic stent | Device: Multiple plastic stents<br>* Deployment of multiple plastic stents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative stent patency | Proportion of patients with documented stent dysfunction | From the date of randomization though the study completion, assessed up to 1 year. | 
| Clinical success rate | Proportion of patients with total bilirubin level declining > 50 % of the initial value | Four weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall adverse events | Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage. | From the date of randomization until the date of documented adverse events, assessed up to 1 month. | 
| Overall patient survival | Proportion of patients who die from any causes. | From the date of randomization until the date of death from any cause, assessed up to 12 months. | 
| Procedure relate death | Proportion of patients who die from complications related procedure. | From the date of randomization until the date of death from procedure within 7 days | 
| Technical success rate | Proportion of patient who successful underwent stent placement. | From the date of randomization until the last stent deploy, assessed up to 1 day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plastic stent, Endoscopic Retrograde Cholangiopancreatography