Fully covered stents are similar to semi-covered stents with regard to migration in palliative treatment of malignant strictures of the esophagus and gastric cardia: results of a randomized controlled trial.

INTRODUCTION: Stent migration is a significant clinical problem in palliation of malignant strictures in the esophagus and gastro-esophageal junction (GEJ). We have compared a newer design of a fully-covered stent to a widely used semi-covered stent using migration >20 mm as the primary outcome variable. Effects on dysphagia, quality of life (QoL) and re-intervention frequency were also investigated.

METHODS: Patients with dysphagia due to non-curable esophagus/GEJ cancer were randomized to receive either a more recent design of a fully-covered stent (n = 48) or a conventional semi-covered stent (n = 47). Chest x-ray, dysphagia and QoL were studied at baseline, one week, four weeks and three months thereafter.

RESULTS: There were no significant differences either in stent migration distance or in the migration frequency. Stent migration during the total study period occurred in 37.2 % in the semi-covered group compared to 20.0 % for the fully-covered group. Dysphagia was measured with Watson and Ogilvie scores and with the dysphagia module in the QoL scale (QLQ-OG25). On average, there was a tendency to better dysphagia relief for the fully-covered design as scored with the two latter dysphagia instruments (p= 0.081 and p= 0.067) at three months and towards more re-interventions in the semi-covered group (p= 0.083).

CONCLUSION: In spite of its somewhat lower intrinsic radial force, the fully-covered stent was comparable to the conventional semi-covered stent with regard to stent migration. The data further suggest a potential benefit of the fully-covered stent in improving dysphagia in patients with longer life expectancy.