New Methods: Clinical Endoscopy
A new fully covered stent with antimigration properties for the palliation of malignant dysphagia: a prospective cohort study

https://doi.org/10.1016/j.gie.2009.09.023Get rights and content

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.

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.

Section snippets

Patients

Between February 2007 and May 2008, 45 patients with dysphagia caused by esophageal, gastric cardia, or lung cancer were consecutively enrolled in the study. Inclusion criteria were inoperable malignant obstruction of the esophagus or gastric cardia caused by esophageal, cardia, or lung carcinoma. All patients gave written informed consent. Exclusion criteria were an obstruction length of more than 12 cm, tumor growth within 2 cm of the upper esophageal sphincter, and a fistula between the

Functional outcome

Successful placement of 46 SX–ELLA stents was achieved in all 45 patients. Because 1 patient was lost to follow-up, clinical characteristics of 44 patients are shown in Table 1. In all 25 (57%) patients with a tumor located in the distal esophagus or gastric cardia, the stent crossed the gastroesophageal junction. Eight patients died before the 4-week follow-up, with 1 of them having symptoms of hemorrhage and upper abdominal pain that were considered to be related to stent insertion. After 4

Discussion

In this prospective follow-up study of 44 patients, we demonstrated that the SX–ELLA stent provided good symptomatic relief of malignant dysphagia. In addition, we found a low rate of tissue overgrowth (KM = 8%), but a similar frequency of stent migration (KM = 20%), as previously reported with other expandable stents.1, 9, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 In addition, despite the single-wire, braided, low-trauma design, the frequency of hemorrhage and fistula formation was considerable

References (22)

  • A. Mougey et al.

    Esophageal stenting for the palliation of malignant dysphagia

    J Support Oncol

    (2008)
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    DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.

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