Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice

Study Overview
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Brief Summary
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Background: When considering any malignancy with limited life expectancy, palliation and quality of life are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the South African state sector, patients often travel vast distances and spend large amounts of time away from family and social support structures, severely impairing their quality of life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously compounds this problem. The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective and improve quality of life than plastic stents. We propose to do this by means of a randomised trial determining the best method of palliation for inoperable distal common bile duct malignancies in the South African context. Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant distal common bile duct strictures in patients with expected survival of 3 months or more as palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware, hospital stay and readmissions for stent occlusion(patency) and complications Secondary end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in patients receiving a metal or plastic biliary stent as definitive means of palliation of malignant obstructive jaundice Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency, resulting in more cost effective palliation of inoperable malignant jaundice and better quality of life due to fewer stent occlusions/episodes of cholangitis.

Official Title
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Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice

Conditions
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Biliary Obstruction

Intervention / Treatment
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* Device: SEMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic jaundice secondary to malignant distal CBD stricture Contra-indication to resection (advanced disease/advanced age/poor surgical risk) Exclusion Criteria: Hilar/proximal CBD obstruction ECOG performance status 3 or 4 Duodenal obstruction Previous stent placement Inability to comply with follow-up Ascites and liver metastases Not possible to stent endoscopically

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SEMS<br>Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition | Device: SEMS<br>* Comparing plastic and metal stents<br>* Other names: olympus plastic stent;|
| Active Comparator: Plastic stent<br> | Device: SEMS<br>* Comparing plastic and metal stents<br>* Other names: olympus plastic stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall cost comparison of metal versus plastic stent in patients with limited life expectancy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biliary, obstruction, malignant, stent, palliation