Su1503 Dysphagia Relief and Adverse Events Associated With Fully Covered Evolution® Esophageal Stents in Malignant Esophageal Strictures: Does Size Matter?

covered 20-mm SEMS which combines bilateral flared ends and three rows of anchoring flaps on the stent body for the prevention of migration. Aim: To evaluate the clinical efficacy and safety of the HANARO-Utrecht stent for the palliation of malignant dysphagia. Methods: Consecutive patients who underwent HANARO-Utrecht stent placement for palliation of malignant dysphagia in four centers from June 2011 until October 2012 were included. Patients were contacted after 2 weeks and monthly thereafter until death. Technical success, recurrent dysphagia, migration, survival and complications were evaluated. Results: Forty patients (29 men (72.5%), mean age 68 11 years) were included. Malignant dysphagia was caused by esophageal cancer (n 32), malignant extrinsic compression (n 5), tumor recurrence after esophagectomy (n 2) and gastric cancer (n 1). Four patients (10%) had an esophageal-respiratory fistula and 26 patients (65%) had undergone previous radiation and/or chemotherapy. Stent placement was technically successful in 38 patients (95%), in 1 patient the stent collapsed during repositioning and a second stent was placed through the stent and in 1 patient the stent was placed more distally than intended despite repositioning. Thirty-four patients (85%) remained dysphagia free during followup (median 59 days, range 2-397), while 6 patients (17%) had recurrent dysphagia after a median of 39 days (range 9-48), due to stent migration (n 5) and tissue overgrowth (n 1). In 4 of these patients, the stent had partially migrated and could be repositioned endoscopically, while in 2 patients a new stent was placed. One patient presented with recurrent partial migration after 59 days, for which repeat repositioning was performed. Fourteen patients are still alive after a median of 59 days (range 15-397) and 26 patients died after a median of 58 days (range 2-210), due to disease progression (n 20), complicated pneumonia (n 3), cardiac disease (n 1), euthanasia (n 1) and acute hypoxemia due to tumor ingrowth in the trachea (n 1). In total, 24 major complications occurred in 18 patients (47%), including severe pain (n 7), severe nausea and/or vomiting (n 6), bleeding (n 4), aspiration pneumonia (n 4), fistula formation (n 2) and tracheal compression (n 1). Conclusion: Despite the specific anti-migration features of the HANARO-Utrecht stent, migration was the main cause of recurrent dysphagia. We also observed a relatively high complication rate, especially severe pain, nausea and vomiting after placement, further improvements in stent design are needed.