Self-expandable esophageal stent loaded with 125I seeds:: Initial experience in patients with advanced esophageal cancer

Purpose: To prospectively compare the response to treatment with a self- expandable esophageal stent loaded with iodine 125 ( I-125) seeds for intraluminal brachytherapy versus the response to treatment with a conventional self- expandable covered stent in patients with advanced esophageal cancer. Materials and Methods: The study protocol was approved by the institutional ethics committee, and informed consent was obtained from each patient. Patients from one institution who had dysphagia caused by inoperable esophageal cancer were randomly assigned to receive treatment with a stent loaded with 125I seeds ( irradiation stent group) or a conventional covered stent ( control group). After stent implantation, the outcomes were measured in terms of relief of dysphagia, survival time, and complications related to the procedure. Dysphagia was assigned a grade. A P value of less than.05 was considered to indicate a significant difference. Results: The stent was successfully placed in the diseased esophagus in all 53 patients ( 27 patients in the irradiation stent group and 26 patients in the control group). The dysphagia grades significantly improved in both groups within the 1st month after stent placement but were better in the irradiation stent group than in the control group after 2 months ( P <.05). The median and mean survival times were better in the irradiation stent group than in the control group, and the differences were significant ( P <.001). Hemorrhage occurred in 16 ( 30%) patients in both groups combined during follow-up. Conclusion: In patients with advanced esophageal cancer, treatment with an esophageal stent loaded with 125I seeds, compared with that with a conventional covered stent, has potential benefit in that it allows a slightly longer relief of dysphagia and extended survival.