Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice
NCT ID: NCT00731419
Last Updated: 2008-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2007-06-30
2009-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SEMS
Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition
SEMS
Comparing plastic and metal stents
Plastic stent
SEMS
Comparing plastic and metal stents
Interventions
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SEMS
Comparing plastic and metal stents
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Contra-indication to resection (advanced disease/advanced age/poor surgical risk)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Cape Town
OTHER
Responsible Party
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Department of Surgery, University of Cape Town
Principal Investigators
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John M Shaw, FCS, MMed
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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Groote Schuur Hospital
Cape Town, Western Cape, South Africa
Countries
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Central Contacts
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Facility Contacts
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John M Sahw, MBBCh, FCS
Role: primary
Other Identifiers
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144/2007
Identifier Type: -
Identifier Source: org_study_id