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Gastrointest Endosc. 2009 Dec;70(6):1082-9. doi: 10.1016/j.gie.2009.05.032. Epub 2009 Jul 28.

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

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1
Utrecht Palliative Care Center, University Medical Center Utrecht, Utrecht, The Netherlands.

Abstract

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.

Comment in

PMID:
19640521
DOI:
10.1016/j.gie.2009.05.032
[Indexed for MEDLINE]

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