BACKGROUND:Self-expanding metal stents seem to be safer than conventional prostheses for palliation of malignant esophagogastric obstruction. However, recurrent dysphagia caused by tumor ingrowth in uncoated types remains a problem. In addition, prior radiation and/or chemotherapy may entail an increased risk of complications. METHODS:Seventy-five patients with an esophagogastric carcinoma were randomly assigned to placement of a latex prosthesis under general anesthesia or a coated, self-expanding metal stent under sedation. At entry, patients were stratified for location of the tumor in the esophagus or cardia and for prior radiation and/or chemotherapy. RESULTS:Technical success and improvement in dysphagia score were similar in both groups. Major complications were more frequent with latex prostheses (47%) than with metal stents (16%) (odds ratio 4.07: 95% CI [1.35, 12.50], p = 0.014). Recurrent dysphagia was not different between latex prostheses (26%) and metal stents (24%). Hospital stay was longer, on average, after placement of latex prostheses than metal stents (6.3 +/- 5.2 versus 4.3 +/- 2.3 days; p = 0.043). Only prior radiation and/or chemotherapy increased the risk of specific device-related complications with respect to the esophagus (12 of 28 [43%] versus 8 of 47 [17%]; odds ratio 3.66: 95% CI [1.24, 10.82], p = 0.029). CONCLUSIONS: Coated, self-expanding metal stents are associated with fewer complications and shorter hospital stay as compared with latex prostheses, and prior radiation and/or chemotherapy increases the risk of device-related complications with respect to the esophagus.
RCT Entities:
BACKGROUND: Self-expanding metal stents seem to be safer than conventional prostheses for palliation of malignant esophagogastric obstruction. However, recurrent dysphagia caused by tumor ingrowth in uncoated types remains a problem. In addition, prior radiation and/or chemotherapy may entail an increased risk of complications. METHODS: Seventy-five patients with an esophagogastric carcinoma were randomly assigned to placement of a latex prosthesis under general anesthesia or a coated, self-expanding metal stent under sedation. At entry, patients were stratified for location of the tumor in the esophagus or cardia and for prior radiation and/or chemotherapy. RESULTS: Technical success and improvement in dysphagia score were similar in both groups. Major complications were more frequent with latex prostheses (47%) than with metal stents (16%) (odds ratio 4.07: 95% CI [1.35, 12.50], p = 0.014). Recurrent dysphagia was not different between latex prostheses (26%) and metal stents (24%). Hospital stay was longer, on average, after placement of latex prostheses than metal stents (6.3 +/- 5.2 versus 4.3 +/- 2.3 days; p = 0.043). Only prior radiation and/or chemotherapy increased the risk of specific device-related complications with respect to the esophagus (12 of 28 [43%] versus 8 of 47 [17%]; odds ratio 3.66: 95% CI [1.24, 10.82], p = 0.029). CONCLUSIONS: Coated, self-expanding metal stents are associated with fewer complications and shorter hospital stay as compared with latex prostheses, and prior radiation and/or chemotherapy increases the risk of device-related complications with respect to the esophagus.