ORIGINAL ARTICLE: Clinical Endoscopy A fully-covered stent (Alimaxx-E) for the palliation of malignant dysphagia: a prospective follow-up study Madeleen J. Uitdehaag, RN, MSc, Jeanin E. van Hooft, MD, MSc, Els M. L. Verschuur, RN, PhD, Alessandro Repici, MD, PhD, Ewout W. Steyerberg, PhD, Paul Fockens, MD, PhD, Ernst J. Kuipers, MD, PhD, Peter D. Siersema, MD, PhD Rotterdam, Amsterdam, Utrecht, The Netherlands, Milan, Italy Background: The majority of the currently available metal stents are partially covered to reduce migration risk. However, one of the remaining issues is tissue ingrowth through the uncovered stent parts. Objective: To determine efficacy, recurrent dysphagia, and complications of a fully covered stent, ie, the Alimaxx-E stent, and to compare two stent delivery systems, ie, one introducing the stent over a guidewire and one introducing the stent over a small-caliber endoscope. Design: A prospective, follow-up study evaluating a new stent design, with randomization for type of introduc- tion system. Setting: Three tertiary referral centers. Patients: Forty-five patients with inoperable or metastatic esophageal or gastric cardia cancer. Interventions: Stent placement. Main Outcome Measurements: (1) Functional outcome, recurrent dysphagia, complications, and mortality of the Alimaxx-E stent; (2) functional aspects of the delivery system. Results: At 4 weeks after stent placement, the dysphagia score improved in all patients (P ! .001). Twenty-two of 45 patients (49%) developed among them 28 episodes of recurrent dysphagia, predominantly stent migration (n Z 16). Major complications occurred in 9 of 45 patients (20%), with all 5 early ( !1 week) complications (severe pain [n Z 3], hemorrhage [n Z 1], and fever [n Z 1]) occurring in patients in whom the stent was introduced over the endoscope (P Z .02). During follow-up, 44 patients died, 3 (7%) from hemorrhage. Limitation: The Alimaxx-E stent was not randomly compared with other stent designs. Conclusions: Placement of Alimaxx-E stents is safe and produces long-term relief of dysphagia, particularly when introduced over a guidewire. The migration rate of the Alimaxx-E stent is, however, unacceptably high, and an adapted stent design is needed. (Gastrointest Endosc 2009;70:1082-9.) Self-expanding metal or plastic stents are frequently used for the relief of dysphagia from inoperable esopha- geal or gastric cardia cancer. 1,2 During the last few years, procedure-related complications and long-term complica- tions of stent placement have remained unchanged, with rates less than 10% 3-5 and less than 15%, 4,5 respectively. In contrast, recurrent dysphagia after stent placement is a frequently encountered problem, occurring in 30% to 50% of patients, mainly due to nontumoral or tumoral tis- sue ingrowth and overgrowth, stent migration, and, to a lesser extent, food-bolus obstruction. 4,5 The relatively high frequency of recurrent dysphagia has resulted in efforts to improve stent design. Currently, several stent designs are available. 4,6 The most commonly used stents worldwide are the metal, partially covered Ultraflex stent (Boston Scientific, Natick, Mass) and the nonmetal (plastic) fully covered Polyflex stent (Boston Scientific). Non- tumoral and tumoral tissue ingrowth is a frequently observed cause of recurrent dysphagia with Ultraflex stents, 4,5,7,8 whereas stent migration commonly occurs with Polyflex stents. 4,5,9-11 A relatively new stent is the fully covered Niti-S Abbreviations: IQR, interquartile range; HR, hazard ratio. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication. Copyright ª 2009 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.05.032 1082 GASTROINTESTINAL ENDOSCOPY Volume 70, No. 6 : 2009 www.giejournal.org