BACKGROUND/AIMS: Because of the short life expectancy of patients with esophageal cancer, relief of dysphagia associated with low morbidity and mortality must be the aim of any therapeutic strategy. METHODOLOGY: A total of 39 patients with unresectable esophageal cancer were randomly allocated to either receive combined laser-percutaneous radiotherapy (group 1, n = 21) or to have a self-expanding metal stent placed (group 2, n = 18). Some patients in group 2 required initial laser therapy (group 2a, n = 8). Treatment efficacy was evaluated on the basis of improved dysphagia, restenosis, hospital stay, survival time and costs. RESULTS: Both treatments were able to significantly improve dysphagia. Restenosis occurred in 43% of group 1 and 22% of group 2 patients. In group 1, 2 patients had severe bleeding episodes and 2 patients developed esophago-tracheal fistulas. One group 1 patient died due to uncontrollable bleeding and 1 patient to recurrent aspiration. No treatment-related death was observed in group 2. Hospital stay was 30.0 (mean: 5.4) days in group 1, 18.9 (mean: 4.2) days in group 2a and 7.1 (mean: 3.1) days in group 2b. There was no statistical difference between the 3 groups with regard to survival. Costs were highest in group 1 and lowest in group 2b. CONCLUSIONS: The treatment of unresectable esophageal cancer with self-expanding metal stents appears to be simple, safe, as good as laser combined with radiotherapy and cost efficient.
RCT Entities:
BACKGROUND/AIMS: Because of the short life expectancy of patients with esophageal cancer, relief of dysphagia associated with low morbidity and mortality must be the aim of any therapeutic strategy. METHODOLOGY: A total of 39 patients with unresectable esophageal cancer were randomly allocated to either receive combined laser-percutaneous radiotherapy (group 1, n = 21) or to have a self-expanding metal stent placed (group 2, n = 18). Some patients in group 2 required initial laser therapy (group 2a, n = 8). Treatment efficacy was evaluated on the basis of improved dysphagia, restenosis, hospital stay, survival time and costs. RESULTS: Both treatments were able to significantly improve dysphagia. Restenosis occurred in 43% of group 1 and 22% of group 2 patients. In group 1, 2 patients had severe bleeding episodes and 2 patients developed esophago-tracheal fistulas. One group 1 patient died due to uncontrollable bleeding and 1 patient to recurrent aspiration. No treatment-related death was observed in group 2. Hospital stay was 30.0 (mean: 5.4) days in group 1, 18.9 (mean: 4.2) days in group 2a and 7.1 (mean: 3.1) days in group 2b. There was no statistical difference between the 3 groups with regard to survival. Costs were highest in group 1 and lowest in group 2b. CONCLUSIONS: The treatment of unresectable esophageal cancer with self-expanding metal stents appears to be simple, safe, as good as laser combined with radiotherapy and cost efficient.