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.