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.