A new fully covered stent with antimigration properties for the palliation of malignant dysphagia: a prospective cohort study
Received 6 March 2009; accepted 25 September 2009. published online 09 December 2009.
Background
Fully covered stents are designed to resist tissue ingrowth that is often seen with partially covered stents. An issue with fully covered stents is the risk of migration.
Objective
We aimed to determine efficacy, recurrent dysphagia, and complications of the SX–ELLA stent Esophageal HV, which is fully covered to resist tissue ingrowth and has an antimigration ring to withstand migration.
Design
Prospective cohort study.
Setting
Two tertiary referral centers.
Patients
Forty-four patients with malignant esophageal strictures from inoperable or metastatic esophageal or gastric cardia cancer (n = 42) or lung cancer (n = 2).
Interventions
Placement of an SX–ELLA stent.
Main outcome measures
Functional outcome, recurrent dysphagia, complications, and survival.
Results
Dysphagia improved from a median score of 3 (liquids only) before stent placement to 1 (ability to eat some solid food) 4 weeks later (P < .001). Twelve of 44 (Kaplan Meier analysis = 40%) patients developed 18 episodes of recurrent dysphagia of which 6 were caused by stent migration and 2 by tissue overgrowth. In total, 14 episodes of major complications developed in 10 of 44 (Kaplan Meier analysis = 29%) patients, 8 of which were caused by hemorrhage. After a median follow-up of 15 months, 39 patients had died (median survival 110 days), 5 (11%) from hemorrhage.
Limitations
Nonrandomized study design.
Conclusions
Dysphagia caused by esophageal cancer can be successfully palliated by placement of a new, fully covered esophageal stent (SX–ELLA). Although this single-wire braided stent with an antimigration ring is supposed to be less traumatic and to reduce migration, this was not substantiated in this study. Further improvements of stent features are needed to achieve the goals set for this study.
Current affiliations: Departments of Gastroenterology and Hepatology (M.J.U., P.D.S., M.C.W.S., E.M.L.V., E.J.K.), Public Health (E.W.S.), and Internal Medicine (E.J.K.), Erasmus MC-University Medical Center Rotterdam, Rotterdam, The Netherlands, Utrecht Palliative Care Center (M.J.U., F.P.V.) and Department of Gastroenterology and Hepatology (P.D.S.), University Medical Center Utrecht, Utrecht, The Netherlands, Association of Comprehensive Cancer Centers (M.J.U.), Utrecht, The Netherlands
Reprint requests: M.J. Uitdehaag, RN, MSc, Association of Comprehensive Cancer Centers, Postbus 19001, 3501 DA, Utrecht, The Netherlands.
DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
ABSTRACT