A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia

Massimo Conio, Alessandro Repici, Giorgio Battaglia, Giovanni De Pretis, Luigi Ghezzo, Max Bittinger, Helmut Messmann, Jean François Demarquay, Sabrina Blanchi, Michele Togni, Rita Conigliaro, Rosangela Filiberti

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Abstract

OBJECTIVES: Self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. We performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex). METHODS: One hundred one patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (N = 47) or a partially covered Ultraflex (N = 54) stent. Patients with esophagogastric junction (EGJ) malignancy were excluded. RESULTS: Placement was successful in 46 (98%) patients with the Polyflex and 54 (100%) patients with the Ultraflex stent. In one patient, the Polyflex stent could not be placed. After 1 wk, dysphagia was improved by at least 1 grade in 100% of the Polyflex group and in 94% of the Ultraflex group. Major complications were observed in 48% of the Polyflex group and 33% of the Ultraflex group. Intraprocedural perforation occurred in 1 Polyflex and 1 Ultraflex patient. Two Polyflex patients had postprocedural hemorrhage. Twenty (44%) patients with a Polyflex stent and 18 (33%) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multivariate analysis showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95% CI 1.2-4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (P = NS). CONCLUSIONS: No difference was seen in palliation of dysphagia between the two stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.

Original languageEnglish
Pages (from-to)2667-2677
Number of pages11
JournalAmerican Journal of Gastroenterology
Volume102
Issue number12
DOIs
Publication statusPublished - Dec 2007

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ASJC Scopus subject areas

  • Gastroenterology

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