Background: In the palliative treatment of malignant dysphagia, fully covered, retrievable metal stents are not commonly used, mainly due to the high risk of migration. Therefore, we performed a prospective study to evaluate the clinical efficacy of a fully covered, retrievable self-expanding metal stent (Niti-S).
Method: Between October 1998 and February 2009, 100 consecutive patients with malignant esophageal obstruction treated with the fully covered Niti-S stent (Niti-S, Taewoong Medical, Seoul, South Korea) were included. Data collected contained functional outcome, feasibility of endoscopic stent retrieval, recurrent dysphagia, complications, and survival.
Result: At 4 weeks after stent placement, dysphagia significantly improved in all patients (p = 0.000). Recurrent dysphagia occurred in 19 of 100 patients treated with Niti-S stents (19%) mainly due to tumor overgrowth (7/100, 7%), stent migration (6/100, 6%), and food impaction (6/100, 6%). Endoscopic stent retrieval was successful in all the attempted 17 patients (17/100, 17%)--7 overgrowth, 6 stent migration, 2 stent degradation, and 2 severe pain. Major complications were 2 hemorrhage, 2 severe pain, and 1 tracheal compression (5/100, 5%), and minor complications were 10 retrosternal pain and 7 symptomatic gastroesophageal reflux (17/100, 17%). After a median follow-up of 142 days, 97 patients had expired. There was no stent-related mortality or 30-day mortality.
Conclusion: The fully covered, retrievable Niti-S stent has proved its effectiveness for palliation of malignant dysphagia and feasibility of endoscopic retrieval. We estimate its dog-bone shaped flanges at both ends and it being completely covered provide good resistance to migration and overgrowth.