Niti-S Esophageal Covered stent (double anti-reflux type). An observational patient registry|post-market clinical follow-up study

Abstract

Background: Relieving dysphagia is the main goal of palliative care in advanced esophageal cancer. We aimed to evaluate the safety and clinical performance of the Niti-S esophageal double covered, anti-reflux stent (Taewoong Medical, Seoul, Korea) in inoperable carcinoma of the esophagus or gastric cardia. Methods: This was a retrospective patient registry/post-market clinical follow-up study of all patients with esophageal malignant strictures undergoing self-expandable metal stent (SEMS) placement with the Niti-S Esophageal covered stent, double antireflux in a community hospital (AZ St Maarten Mechelen, Belgium) between March 2013 and July 2021. Results: In twenty-nine patients, thirty self-expandable metal stents (SEMS) were placed. The median dysphagia score before stent placement was 3 and 0 after stent placement (p < 0.001). Stent migration did not occur. Two patients (7%) had new onset reflux symptoms. The most common adverse event was retrosternal pain (5 patients, 17%). One patient (3%) had recurrent dysphagia due to proximal tumoral overgrowth and two patients (7%) because of proximal benign tissue overgrowth. There were no perforations, fistula formations or episodes of food impaction. Conclusion: The Niti-S esophageal double covered, antireflux stent (Taewoong Medical, Seoul, Korea) is an effective and safe treatment option for malignant esophageal stenosis.