Lisa Gensthaler, Johanna Bauer, Dagmar Kollmann, Milena Bologheanu, Joy Feka, Ivan Kristo, Gerd Jomrich, Erwin Rieder, Reza Asari, Sebastian F Schoppmann
{"title":"Treatment of malignant esophageal stricture or esophageal leakage with a Niti-S™ covered anti-reflux stent is safe and efficient.","authors":"Lisa Gensthaler, Johanna Bauer, Dagmar Kollmann, Milena Bologheanu, Joy Feka, Ivan Kristo, Gerd Jomrich, Erwin Rieder, Reza Asari, Sebastian F Schoppmann","doi":"10.1007/s00423-026-04111-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Materials and methods: </strong>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><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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>","PeriodicalId":17983,"journal":{"name":"Langenbeck's Archives of Surgery","volume":" ","pages":""},"PeriodicalIF":2.2000,"publicationDate":"2026-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13541975/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Langenbeck's Archives of Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00423-026-04111-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Langenbeck''s Archives of Surgery aims to publish the best results in the field of clinical surgery and basic surgical research. The main focus is on providing the highest level of clinical research and clinically relevant basic research. The journal, published exclusively in English, will provide an international discussion forum for the controlled results of clinical surgery. The majority of published contributions will be original articles reporting on clinical data from general and visceral surgery, while endocrine surgery will also be covered. Papers on basic surgical principles from the fields of traumatology, vascular and thoracic surgery are also welcome. Evidence-based medicine is an important criterion for the acceptance of papers.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
