Elsevier

Gastrointestinal Endoscopy

Volume 70, Issue 6, December 2009, Pages 1082-1089
Gastrointestinal Endoscopy

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

https://doi.org/10.1016/j.gie.2009.05.032Get rights and content

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.

Section snippets

Patients and methods

Between March 2006 and January 2007, all consecutive patients with dysphagia due to esophageal or gastric cardia cancer who met the inclusion and did not meet the exclusion criteria of the study and gave informed consent were treated with an Alimaxx-E stent. Inclusion criteria included an inoperable malignant obstruction of the esophagus or gastric cardia, or recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer. A tumor was

Clinical characteristics

Clinical characteristics of 45 patients treated with an Alimaxx-E stent are shown in Table 1. The length of the tumor was longer for patients treated with the Alimaxx-E GW system (mean 7.7 cm; SD 1.8) than for those treated with the Alimaxx-E DV system (mean 6.4 cm; SD 2.2 [P =.04]). All other characteristics were not different between the 2 introduction systems.

Procedural characteristics

In total, 22 patients were treated with the Alimaxx-E GW system and 23 with the Alimaxx-E DV system (Table 2). In 11 of 23 (48%)

Discussion

In this prospective follow-up series of 45 patients treated with an Alimaxx-E stent for dysphagia due to inoperable carcinoma of the esophagus or gastric cardia, we showed that this new stent design provided good symptomatic relief of malignant dysphagia. Placement of an Alimaxx-E stent was also safe and was not associated with a higher incidence of complications compared with those found in previous studies with other stent designs, ie, Niti-S stents, Polyflex stents, and Ultraflex stents.4, 5

References (20)

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DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.

Presented at Digestive Disease Week, May 17-22, 2008, San Diego, California (Gastrointest Endosc 2008:67:AB250).

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