A multicenter, prospective randomized trial comparing two types of self-expanding stents in the palliation of malignant dysphagia: SEMS (Ultraflex stent) versus SEPS (Polyflex stent)

Aims: High-grade dysphagia is the predominant late symptom of local advanced esophagogastric cancer. Placement of self-expandable metal stents (SEMS) is an established method of treatment for inoperable esophagogastric cancers. The major disadvantage of SEMS is its high upfront costs. A new self-expandable plastic stent (SEPS) has been developed recently.

Aim and methods: To evaluate efficacy and outcome of a special type of SEMS (Ultraflex stent) versus the new designed SEPS (Polyflex stent) in malignant dysphagia. Multicenter, prospective randomized trial of 47 patients (pts.) with malignant dysphagia. 23 pts. received a SEMS while 24 pts. were treated with SEPS. There were 13 females and 34 males with a median age of 71.5 (range 32–80) years. Pre- and post-stent dysphagia symptom was graded on a scale from 0 to 4 (0=normal swallowing, 1=dysphagia for solids only, 2=dysphagia for semi-solids also, 3=dysphagia for liquids also, 4=cannot swallow own saliva). Ultraflex stents (SEMS) and Polyflex stents (SEPS) were compared for improvement of dysphagia score, survival, recurrent dysphagia, Karnofsky-performance-score (KPS) and complications.

Results: Primary stent placement was successful in 23/23 (100%) pts. in the SEMS group and 23/24 (96%) pts. of the SEPS group. Median hospital stay after implantation was 3.2 days (SEMS) and 4.1 days (SEPS)(p=0.43). After 1 and 4 weeks after stenting, median dysphagia score improved in the SEMS group (from 3.03 to 1.17) and the SEPS group (from 2.99 to 1.24), the improvement without significant difference between both groups (p=0.37). Duration of improvement of dysphagia was 51 days (SEMS) and 76 days (SEPS) (p=0.09). Recurrrent dysphagia was noted in 6/23 (26%) pts. with SEMS and 10/24 (42%) of pts. with SEPS (p=0.02). Median survival after insertion of the stent was 209 days (SEMS) and 191 days (SEPS). Migration of the stent was seen significantly (p=0.01) more often in the SEPS group than in the SEMS group (29% vs. 4%).

Conclusion: Our results indicate a potential benefit for SEMS versus the newly designed SEPS in malignant dysphagia in the long run. The migration rate was significantly higher after insertion of a SEPS. SEMS seems to be safer and related with a prolonged improvement of dysphagia-score.