Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice
- Conditions
- Biliary Obstruction
- Interventions
- Device: SEMS
- Registration Number
- NCT00731419
- Lead Sponsor
- University of Cape Town
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Symptomatic jaundice secondary to malignant distal CBD stricture
- Contra-indication to resection (advanced disease/advanced age/poor surgical risk)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEMS SEMS Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition Plastic stent SEMS -
- Primary Outcome Measures
Name Time Method Overall cost comparison of metal versus plastic stent in patients with limited life expectancy 6 months
- Secondary Outcome Measures
Name Time Method Quality of life assessment 6 months
Trial Locations
- Locations (1)
Groote Schuur Hospital
🇿🇦Cape Town, Western Cape, South Africa