Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice
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|ClinicalTrials.gov Identifier: NCT00731419|
Recruitment Status : Unknown
Verified May 2007 by University of Cape Town.
Recruitment status was: Recruiting
First Posted : August 11, 2008
Last Update Posted : August 11, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Biliary Obstruction||Device: SEMS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||August 2009|
Active Comparator: SEMS
Self expanding metal stent compared to plastic stent. Both recognised forms of treatment for condition
Comparing plastic and metal stents
|Active Comparator: Plastic stent||
Comparing plastic and metal stents
- Overall cost comparison of metal versus plastic stent in patients with limited life expectancy [ Time Frame: 6 months ]
- Quality of life assessment [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731419
|Contact: John M Shaw, FCS, MMed||021-404-3042||John.Shaw@uct.ac.za|
|Contact: Jake E Krige, FCS, FACS||021-404-3072||Jake@curie.uct.ac.za|
|Groote Schuur Hospital||Recruiting|
|Cape Town, Western Cape, South Africa, 7925|
|Contact: John M Sahw, MBBCh, FCS 021-404-3042 John.Shaw@uct.ac.za|
|Principal Investigator: John M Shaw, MBBCH,FCS|
|Principal Investigator:||John M Shaw, FCS, MMed||University of Cape Town|