A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Palliation of malignant biliary obstruction
Groote Schuur Hospital
Cape Town, Western Cape, South Africa
RECRUITINGNumber of patients without stent failure
Number of patients without Stent failure (jaundice) or death with a patent stent
Time frame: 12 months
Overall survival
Number of patietns alive in each group at 12 months
Time frame: 12 months
Stent deployment failure
Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation
Time frame: During procedure
Cost
The differance in treatment costs between the two groups, measured in USD
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.