Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: A randomized prospective study

Background: A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. Methods: A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n = 66) or uncovered unfixed-cell braided (n = 68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. Results: 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p = 0.999. Stent migration was more frequent in the covered group than in the uncovered group (p = 0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p = 0.016). Conclusions: The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. (C) 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.