Background: Stents are commonly used for the palliation of obstruction due to irresectable esophageal or gastric cardia cancer. One of the drawbacks of the presently used stents is the high percentage of recurrent dysphagia due to stent migration and tissue growth. New stents have been designed to overcome this unwanted sequel of stent placement. Aim: To compare the partially-covered Ultraflex stent (Boston Scientific, Natick, USA), with the newly designed fully covered Polyflex stent made of silicone with an encapsulated monofilament braid of polyester (Boston Scientific), and the Niti-S stent consisting of an inner polyurethane layer over its complete length and an outer uncovered nitinol wire (Taewoong Medical, Seoul, Korea) in patients with inoperable carcinoma in the esophagus or gastric cardia. Methods: Between June 2004 and May 2006, 125 patients were randomized to treatment with an Ultraflex stent (n = 42), Polyflex stent (n = 41) or Niti-S stent (n = 42). Patients were followed by scheduled telephone calls at 14 days after treatment, and then monthly for six months or until death. Recurrence of dysphagia, technical and functional outcome, and complications were analyzed with Kaplan-Meier curves and log rank testing. Health-related quality of life was assessed by EORTC C30 and EORTC OES18 questionnaires. Results: Technical problems occurred in 9 (7%) patients, mainly with a Polyflex stent (n = 7). Dysphagia improved from a median score of 3 (liquids only) to 1 (ability to eat some solid food) in all 3 stent groups. Recurrent dysphagia occurred more frequently with Ultraflex stents (p = 0.03), and was caused by tissue growth (Ultraflex stent 13/42 (31%) vs. Polyflex stent 4/41 (10%) vs. Niti-S stent 10/42 (24%)), stent migration (Ultraflex stent 7/42 (17%) vs. Polyflex stent 12/41 (29%) vs. Niti-S stent 5/42 (12%)), and food bolus impaction (Ultraflex stent 10/42 (24%) vs. Polyflex stent 2/41 (5%) vs. Niti-S stent 1/42 (2%)). There were no differences in complications between the three stent types, however two perforations occurred with Polyflex stents. No differences were found in general and disease-specific quality of life scores between the three stent types. Conclusions: All three stents are safe and offer the same degree of palliation from malignant dysphagia. The new fully covered stents have the advantage that re-interventions are less frequently needed, as the Polyflex particularly reduces tissue growth and the Niti-S stent migration rates. It may well be that recurrent dysphagia could be even more reduced by designing a stent that combines the non-metal material used for the Polyflex stent with the anti-migration wire of the Niti-S stent.
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