Randomized clinical trial comparing self-expanding metallic stents with plastic endoprostheses in the palliation of oesophageal cancer

Abstract

Background There is little evidence of the clinical and cost effectiveness of self-expanding metallic stents in the palliation of oesophageal cancer. The aims of this randomized trial were to evaluate the immediate and medium-term clinical outcomes following palliative intubation, examine patient quality of life, and evaluate costs and benefits from the perspective of the health service. Methods Fifty patients with inoperable oesophageal cancer were randomly allocated a metallic stent (n = 25) or plastic endoprosthesis (n = 25). Patients were followed up monthly until death. Results There was no significant difference in procedure-related complications or mortality rate between the two groups. There was a trend towards significance in favour of metallic stents with respect to quality of life and survival (median survival 62 versus 107 days for plastic prosthesis and metallic stent respectively). The cost of the initial placement of metallic stents was significantly higher than that of plastic endoprostheses (£983 versus£296). After 4 weeks, cost differences were no longer significant. Conclusion Metallic stents may contribute to improved survival and quality of life in patients with oesophageal cancer. Although initially more expensive, this cost difference does not last beyond 4 weeks. A larger trial involving approximately 300 patients would be required to detect a quality of life benefit of the magnitude observed in this trial.