Comparison of double‐layered and covered Niti‐S stents for palliation of malignant dysphagia

Abstract

Covered metal stents have been accepted as the treatment of choice for malignant dysphagia caused by esophageal and gastric cardia cancer, but stent migration is a major shortcoming. A double-layered Niti-S stent was therefore introduced to obviate this problem. We aimed to compare double-layered and covered Niti-S stents regarding safety, efficacy, and feasibility in the treatment of malignant dysphagia. Thirty-seven consecutive patients with malignant dysphagia due to inoperable esophageal or gastric cardia cancer were enrolled in a prospective, randomized study. The main outcomes were technical success, improvement in dysphagia score after stent insertion, and complications. Technical success was achieved at a similar rate in both groups (covered, 19/19 [100%]vs double layered, 16/17 [94%]). A week after stent insertion, the mean dysphagia score improved significantly in the covered and double-layered groups compared to baseline (from 2.95 +/- 0.52 and 2.88 +/- 0.33 to 1.00 +/- 0.47 and 1.06 +/- 0.24, respectively; P < 0.001). There was no difference in the survival of the patients in the two groups. The overall complications, including stent migration and tumor overgrowth, occurred more frequently with covered stents (11/19 [58%]) than double-layered stents (2/17 [12%]; P = 0.006). Newly-developed, self-expanding metal stents, (covered and double-layered Niti-S stents) were equally effective and feasible treatments for malignant dysphagia. However, double-layered Niti-S stents are preferable due to their favorable safety profile.