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

Ahead of print available from 21/06/2022
These articles are scheduled for publication in Vol. 85 (3) 2022

Author(s) L. Van Overbeke 1, J. van Dongen 1
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(1) Department of Gastroenterology and Hepatology, AZ St. Maarten, Mechelen, Belgium.

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.

Keywords: esophageal cancer, esophageal adenocarcinoma, selfexpandable metal stent
© Acta Gastro-Enterologica Belgica.