Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction

Study Overview
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Brief Summary
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A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.

Official Title
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Treatment of Malignant Distal Biliary Obstruction - a Randomized Study

Conditions
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Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas, Cancer of the Bile Duct, Biliary Stricture

Intervention / Treatment
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* Device: Biliary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18years of age or older informed consent obtained after oral and written information clinical data in accordance with a malignant bile duct obstruction imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction typical ERCP findings of a malignant common bile duct stenosis proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence bilirubin > 50 micromol/L radical surgery not deemed possible Exclusion Criteria: patients with active hepatitis or other jaundice-causing hepatic diseases informed consent not obtained or patient unable to give informed consent patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria) the patient is a possible candidate for surgical resection suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations) the proximal end of the stenosis is < 2 cm from the hepatic confluence previous BII or Roux-en-Y gastric reconstruction significant duodenal obstruction making ERCP difficult previous bile duct stent

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: Multiple Plastic Stents<br>Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture. | Device: Biliary stent<br>* Palliation of malignant biliary obstruction<br>|
| Active Comparator: Self-expandable Metal Stents<br>Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture | Device: Biliary stent<br>* Palliation of malignant biliary obstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients without stent failure | Number of patients without Stent failure (jaundice) or death with a patent stent | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Number of patietns alive in each group at 12 months | 12 months | 
| Stent deployment failure | Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation | During procedure | 
| Cost | The differance in treatment costs between the two groups, measured in USD | 12 months |