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.