A new fully covered stent with antimigration properties for the palliation of malignant dysphagia: a prospective cohort study.

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.