A prospective randomised trial comparing plastic and uncovered self-expanding metal stents for palliation of symptomatic jaundice in patients with malignant distal biliary obstruction

Master Thesis


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University of Cape Town

The aim of this study was to determine the safety and clinical effectiveness of 10Fr plastic biliary stents compared to uncovered self-expanding metal stents (SEMS) for palliative treatment of patients with inoperable malignant distal biliary obstruction in a public hospital in South Africa. Methods: From January 2009 to December 2013, 40 patients who were admitted to a tertiary academic centre because of distal malignant biliary obstruction were enrolled in a prospective randomised study. Patients were randomly assigned to receive either an uncovered SEMS or a plastic stent deployed through the biliary stricture during endoscopic retrograde cholangiopancreatography. Results: Patient survival time in the two groups did not differ significantly (median: SEMS - 114 days; plastic - 107 days) (p=0.181). Stent failure was more common in the plastic stent group (7/19 vs. 1/20) (p=0.043). The results became significant after 6 months of follow up. There was no significant difference between the two groups in the incidence of serious adverse events. Conclusions: SEMS had a longer duration of patency than plastic stents, which favours their use in the palliative treatment of patients with biliary obstruction due to distal malignant biliary obstruction.