PURPOSE: To evaluate the long-term clinical outcomes and the negative predictors after the deployment of double-layered stents in malignant esophageal strictures. METHODS: This is a single-center study of patients who received a double-layered covered stent for the palliation of dysphagia due to malignant esophageal strictures in a 3-year period. 56 patients fulfilled the inclusion criteria. The study's primary end points were technical success, dysphagia improvement, stent migration, and complication rates; secondary end points were the stent's primary patency and overall survival. Cox regression analysis was used to adjust for confounding variables and to identify predictors of survival outcomes. RESULTS: Technical success was 95%. Median dysphagia score improved significantly after stenting (p < 0.0001). Stent migration rate was 7.1% and occurred exclusively in the group of patients who received chemoradiotherapy (p < 0.01). The median stent patency was 87 days (range 5-444 days). Dysphagia reoccurred in 39.3% and was successfully managed with restenting in 98.2%. The median survival was 127 days (range 15-1480 days). Chemoradiotherapy and baseline histology did not influence survival outcomes. Survival was adversely affected by metastases (p = 0.005) and poor oral intake (p = 0.048). Patient survival was improved by repeat stenting in case of tissue overgrowth (p = 0.06). CONCLUSION: The device is safe and effective for the treatment of patients with dysphagia due to esophageal cancer. Migration rate is zero for patients who do not receive chemoradiotherapy. Reintervention when required is a positive survival predictor.
PURPOSE: To evaluate the long-term clinical outcomes and the negative predictors after the deployment of double-layered stents in malignant esophageal strictures. METHODS: This is a single-center study of patients who received a double-layered covered stent for the palliation of dysphagia due to malignant esophageal strictures in a 3-year period. 56 patients fulfilled the inclusion criteria. The study's primary end points were technical success, dysphagia improvement, stent migration, and complication rates; secondary end points were the stent's primary patency and overall survival. Cox regression analysis was used to adjust for confounding variables and to identify predictors of survival outcomes. RESULTS: Technical success was 95%. Median dysphagia score improved significantly after stenting (p < 0.0001). Stent migration rate was 7.1% and occurred exclusively in the group of patients who received chemoradiotherapy (p < 0.01). The median stent patency was 87 days (range 5-444 days). Dysphagia reoccurred in 39.3% and was successfully managed with restenting in 98.2%. The median survival was 127 days (range 15-1480 days). Chemoradiotherapy and baseline histology did not influence survival outcomes. Survival was adversely affected by metastases (p = 0.005) and poor oral intake (p = 0.048). Patient survival was improved by repeat stenting in case of tissue overgrowth (p = 0.06). CONCLUSION: The device is safe and effective for the treatment of patients with dysphagia due to esophageal cancer. Migration rate is zero for patients who do not receive chemoradiotherapy. Reintervention when required is a positive survival predictor.