Distal malignant biliary obstruction: a prospective randomised trial comparing plastic and uncovered self-expanding metal stents

Abstract

Background: The aim of this study was to determine the safety and clinical effectiveness of 10F plastic biliary stents compared to uncovered self expanding metal stents (SEMS) for palliative treatment of patients with inoperable extra-hepatic malignant 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 randomized study. Patients were randomly assigned to receive an uncovered SEMS or a plastic stent deployed through the biliary stricture during endoscopic retrograde cholangiopancreatography. Results: Median patient survival time in the two groups did not differ significantly (SEMS - 114 days; plastic - 107 days). Stent failure was more common in the plastic stent group (7/19 vs. 1/20). 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. Conclusion: SEMSs had a longer duration of patency than plastic stents, which recommends their use in the palliative treatment of patients with biliary obstruction due to distal malignant biliary obstruction.