Comparison of Two Expandable Endoprosthesis for Benign Esophageal Disease

The treatment of benign esophageal perforations and severe strictures is a
major challenge. Many patients are medically unfit for surgery and the overall
prognosis is so poor that an alternative approach is needed to restore the
luminal patency or the esophageal wall defect. Deployment of a covered
expandable endoprosthesis provides a minimally invasive alternative in these
cases.
The mortality rate of Boerhaave*s syndrome, when left untreated, is reported to
be as high as a 100%. Promising results for benign esophageal perforations have
been achieved by using self-expandable metal stents (SEMS). Besides sealing
perforations, SEMS are also effective for the relief of dysphagia in benign
esophageal stenosis; such as stricture after esophageal surgery, mediastinal
radiotherapy or caustic ingestions. Endoscopic dilation, by using bougies or
balloons, is the treatment of choice for non-malignant esophageal stenoses.
However, when symptoms of dysphagia reoccur, stent insertion can be a good
alternative therapy.
Temporary SEMS placement however, carries risks and complications; including
stent related haemorrhages, perforations, or stent migration. Stents should be
removed within 6 weeks after- insertion, to minimise the risk of removal.
Several types of metal expandable stents are available with various deployment
systems. Two commonly used stents are the Ultraflex stent and the Hanarostent
stent. Both stents differ in delivery system, removability and design. The
proximally flared Ultraflex stent has distally uncovered segments which allow
the normal mucosa above and below the lesion to project into the stent lumen.
The Hanarostent stent is fully covered and it differs from the Ultraflex stent
in the angulation between the body and the flanges. In this prospective
randomized study, we will compare the Ultraflex stent with the Hanarostent in
patients with benign esophageal lesions.

The primary objective of this study is to compare the stent migration rate of
two metal expandable stents in patients with benign esophageal conditions.

The secondary objectives are:
• To compare the technical outcome.
• To compare the functional outcome.
• To compare the re-intervention rate.
• To compare procedure related complications.
• To compare the success of stent removal.
• To determine the mortality rate, within 30 days of intervention.

This is a multicenter, randomized, open-label clinical study. All patients that
meet the inclusion criteria will be asked to participate by their treating
physician. Patients will be included and randomized after written informed
consent.

stent insertion --> Ultraflex stent or Hanarostent

n.a.