A Comparison of Two Expandable Metal Stents for the Palliation of Malignant Esophageal Disease

Over the past 20 years, a wide variety of expandable esophageal endoprostheses
have been developed to improve placement and reduce stentdysfunction. At
present, the Ultraflex® stent (Boston Scientific, USA) is the most frequently
used stent. The Ultraflex stent has a polyurethane covered flexible
knitted-loop design. The stent has a proximal flange and both proximal and
distal a non-covered segment to reduce the risk of migration. The Ultraflex
stent is not designed to be repositioned or removed once deployed, although
endoscopic removal is often feasible.
The recently designed Evolution Controlled Release Stent (Wilson-Cook Medical,
USA) has a silicone sandwich covering. The stent has two uncovered flanges at
the proximal and distal end to anchor the stent and reduce the risk of
migration. The Evolution stent has a novel delivery system that makes the stent
recapturable to allow for repositioning during deployment. The *lasso* loop on
the proximal end enables stent removal and repositioning after deployment.

In this prospective randomized study, we will compare the conventional
Ultraflex stent with the newly designed Evolution stent for the palliation of
patients with malignant esophageal disease.

To compare the conventional Ultraflex® Stent with the newly designed Evolution®
Controlled Release Stent for the palliation of patients with malignant
esophageal disease.

Patients, 18 years of age and older, referred for palliative stent placement
for malignant esophageal disease are eligible for this study after written
informed consent.

• Insertion of the Ultraflex® Stent (group 1) or the Evolution® Controlled
Release Stent (group 2)

None. Stent therapy is a standard therapy for this population.