Biliary Obstruction Clinical Trial
Official title:
Distal Malignant Biliary Obstruction: A Prospective Randomised Trial Comparing Metal and Plastic Stents in Palliation of Symptomatic Jaundice
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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