A fully-covered stent (Alimaxx-E) for the palliation of malignant dysphagia: a prospective follow-up study.

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 introduction 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 = 16). Major complications occurred in 9 of 45 patients (20%), with all 5 early (<1 week) complications (severe pain [n = 3], hemorrhage [n = 1], and fever [n = 1]) occurring in patients in whom the stent was introduced over the endoscope (P = .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.