NITINOL PROSTHESES FOR THE TREATMENT OF INOPERABLE MALIGNANT ESOPHAGEAL OBSTRUCTION

PURPOSE: This uncontrolled prospective study was undertaken to evaluate a new nitinol stent in the treatment of dysphagia due to inoperable malignant esophageal obstruction. PATIENTS AND METHODS: Eighteen consecutive patients (15 men, three women; mean age, 66 years +/- 15) with inoperable malignant obstructions of the esophagus or esophagogastric junction due to esophageal carcinoma (n = 14) or extrinsic obstruction (n = 4) were treated with self-expanding nitinol endoprostheses (diameter, 18 mm). Dysphagia score and activity index were assessed before and every 4 weeks after stent insertion. RESULTS: Eighteen stents were deployed successfully. One stent expanded insufficiently and was removed inadvertently during retrieval of the application system. Mean time until complete expansion of the stent was 7.1 days +/- 5. Stent placement resulted in a significant decrease in the dysphagia score (2,7 +/- 0.7 before vs 0.6 +/- 0.7 after stent placement, P < .00005 by Wilcoxon matched-pairs test) and a significant increase in the activity index (2.6 +/- 1 before vs 1.7 +/- 0.9 after stent insertion; P < .005). There were no procedure-related complications. Follow-up period (mean, 155 days +/- 100) revealed recurrent dysphagia in four patients. Two patients experienced food bolus impaction, another two had tumor ingrowth through the mesh after 170 and 186 days. Fourteen patients died after a mean survival time of 158 days +/- 106, all with patent stents. CONCLUSIONS: Self-expanding nitinol esophageal stents are safe and effective in the treatment of malignant esophageal obstructions.