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Background <p>Self-expanding metal stents (SEMS) are a palliative treatment option for malignant esophageal strictures causing dysphagia. Retrosternal pain, reflux-related symptoms and migration remain relevant limitations. SEMS with an anti-reflux valve (SEMS-ART; Niti-S<b>™</b> esophageal covered stent, anti-reflux type, TaeWoong Medical) may reduce these limitations but clinical data remain limited. This study evaluates safety, tolerability and clinical performance of SEMS-ART in malignant esophageal stricture and leakage.</p> Materials and methods <p>All patients treated with SEMS-ART for malignant esophageal stricture or leakage at the Medical University of Vienna, Department of General Surgery, between 01/2016 and 04/2021 were included into this retrospective analysis. Parameters regarding patients’ safety, compliance and associated comorbidities like reflux and dysphagia were analyzed.</p> Results <p>Twenty patients were included. The cohort was predominantly male (90.0%) with a mean age of 65.3 years. Advanced esophageal cancer UICC stage III–IV was present in 75.0%. Technical success was achieved in all patients (100%). Adequate stent expansion was confirmed in all patients, while correct positioning and normal contrast passage were observed in 95%. Reflux, Dysphagia and Regurgitation resolved in all cases after SEMS insertion (<i>p</i> &lt; 0.001). Dislocation occurred in 15.0% (<i>n</i> = 3) and primarily managed endoscopically. Mean SEMS dwell time was 88.3 days. 30-day SEMS-related safety was 95.0%, and no SEMS-related mortality occurred within the observational period.</p> Conclusion <p>This small case series demonstrates high technical success of SEMS-ART, supporting feasibility and an acceptable safety profile on migration and symptom relief. These findings support the use of SEMS-ART in selected patients with malignant esophageal stricture and should be considered hypothesis-generating, supporting further prospective comparative studies.</p>

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Treatment of malignant esophageal stricture or esophageal leakage with a Niti-S™ covered anti-reflux stent is safe and efficient

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月23日

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  • Lisa Gensthaler,
  • Johanna Bauer,
  • Dagmar Kollmann,
  • Milena Bologheanu,
  • Joy Feka,
  • Ivan Kristo,
  • Gerd Jomrich,
  • Erwin Rieder,
  • Reza Asari,
  • Sebastian F. Schoppmann

摘要

Background

Self-expanding metal stents (SEMS) are a palliative treatment option for malignant esophageal strictures causing dysphagia. Retrosternal pain, reflux-related symptoms and migration remain relevant limitations. SEMS with an anti-reflux valve (SEMS-ART; Niti-S™ esophageal covered stent, anti-reflux type, TaeWoong Medical) may reduce these limitations but clinical data remain limited. This study evaluates safety, tolerability and clinical performance of SEMS-ART in malignant esophageal stricture and leakage.

Materials and methods

All patients treated with SEMS-ART for malignant esophageal stricture or leakage at the Medical University of Vienna, Department of General Surgery, between 01/2016 and 04/2021 were included into this retrospective analysis. Parameters regarding patients’ safety, compliance and associated comorbidities like reflux and dysphagia were analyzed.

Results

Twenty patients were included. The cohort was predominantly male (90.0%) with a mean age of 65.3 years. Advanced esophageal cancer UICC stage III–IV was present in 75.0%. Technical success was achieved in all patients (100%). Adequate stent expansion was confirmed in all patients, while correct positioning and normal contrast passage were observed in 95%. Reflux, Dysphagia and Regurgitation resolved in all cases after SEMS insertion (p < 0.001). Dislocation occurred in 15.0% (n = 3) and primarily managed endoscopically. Mean SEMS dwell time was 88.3 days. 30-day SEMS-related safety was 95.0%, and no SEMS-related mortality occurred within the observational period.

Conclusion

This small case series demonstrates high technical success of SEMS-ART, supporting feasibility and an acceptable safety profile on migration and symptom relief. These findings support the use of SEMS-ART in selected patients with malignant esophageal stricture and should be considered hypothesis-generating, supporting further prospective comparative studies.