Thieme E-Journals - Zeitschrift für Gastroenterologie / Abstract
Z Gastroenterol 2008; 46 - P425
DOI: 10.1055/s-0028-1089800

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)

C Schlott 1, A Eickhoff 1, R Kiesslich 2, S Turi 3, JC Eickhoff 4, R Jakobs 1, JF Riemann 1
  • 1Klinikum Ludwigshafen, Medizinische Klinik C, Ludwigshafen, Germany
  • 2I. Medizinische Klinik J. Gutenberg Universität, Mainz, Germany
  • 3Ernst-Moritz-Arndt-Universität Greifswald, Klinik für Gastroenterologie, Greifswald, Germany
  • 4University of Wisconsin,, Department of Biostatistics and Medical Informatics, Madison, WI, United States of America

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.

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 60 patients (pts.) with malignant dysphagia due to esophagogastric cancer. 30 pts. received a SEMS and 30 pts. were treated with SEPS. There were 23 females and 37 males with a median age of 70.3 (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 30/30 (100%) pts. in the SEMS group and 29/30 (97%) pts. of the SEPS group. Median hospital stay after implantation was 2.9 days (SEMS) and 3.7 days (SEPS)(p=0.48). After 1 and 4 weeks after stenting, median dysphagia score improved in the SEMS group (from 3.15 to 1.23) and the SEPS group (from 2.84 to 1.26), the improvement without significant difference between both groups (p=0.28). Duration of improvement of dysphagia was 85 days (SEMS) and 61 days (SEPS) (p=0.09). Recurrrent dysphagia was noted in 8/30 (27%) pts. with SEMS and 13/30 (43%) of pts. with SEPS (p=0.02). Median survival was 201 days (SEMS) and 180 days (SEPS). Migration of the stent was seen significantly (p=0.01) more often in the SEPS group than in the SEMS group (28% 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.