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

Abstract

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.