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Antireflux stent versus conventional stent in the palliation of distal esophageal cancer. A randomized, multicenter clinical trial

Abstract Objective. Patients with incurable distal esophageal or cardia cancer often need palliative stenting to relieve their dysphagia but stents passing through the cardia can cause reflux and aspiration, leading to a reduced health-related quality of life (HRQL). This study addressed the hypothesis that antireflux stenting improves HRQL compared to conventional stenting. Material and methods. In a single-blind, multicenter, randomized trial in patients with inoperable esophageal or cardia cancer requiring palliative stenting passing through the cardia, 65 patients were stented. Patients received either an antireflux stent (Esophageal Z-Stent with Dua antireflux valve; n = 28) or a conventional stent (Esophageal Z-stent, Ultraflex or Wallstent; n = 37). Validated questionnaires (European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-OES18) were used to collect information on HRQL at baseline and 1 and 3 months after stenting. Main outcome measurements were differences in HRQL scores between baseline and 1 and 3 months after stenting. Results. Scores for most aspects of HRQL were similar in the two groups, and no statistically significant differences were found. Some general symptoms however showed clinically relevant improvement in the antireflux stent group, while esophageal-specific symptoms such as dysphagia seemed clinically better, and symptoms of reflux were clinically reduced in the conventional stent group but not in the antireflux stent group. Conclusion. This study, although limited in size, provided no obvious support for using the antireflux stent in preference to the conventional stent in the palliation of distal esophageal or cardia cancer from an HRQL perspective.