Distal malignant biliary obstruction: a prospective randomised trial comparing plastic and uncovered self-expanding metal stents in the palliation of symptomatic jaundice.

BACKGROUND: 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 extra-hepatic malignant biliary obstruction in a public hospital in South Africa.

METHOD: 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 (ERCP).

RESULTS: Patient survival time in the two groups did not differ significantly (median: SEMS - 114 days; plastic - 107 days). Stent failure was more common in the plastic stent group (7/19 vs. 1/21). 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: SEMS 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.