Development of a new biliary intraluminal irradiation stent and the primary results of clinical application

Abstract

To evaluate the feasibility, safety and efficiency of a new biliary intraluminal irradiation stent system loaded with (125)I seeds. The study was approved by the institutional ethics committee of our hospital, and informed consent was obtained from each patient. Patients with malignant biliary obstruction were treated with a new biliary irradiation stent system loaded with (125)I seeds according to a treatment plan system. All of the biliary seeds carrying devices combined with the matched biliary stents were placed by the procedures of percutaneous transhepatic biliary puncture. After stents implantation, all patients were followed-up. The whole biliary stent systems loaded with (125)I seeds were successfully placed in 12 patients, no (125)I seeds exfoliation during the procedure and no radioactive leakage by general emission computed tomography reexamination during the follow-up were observed. The obstructive jaundice relived and the systemic conditions improved remarkably in all patients. There were no complications related to the stents, such as biliary perforation or hemobilia, were observed. And no significant change in the blood routine and immune parameters detected before and after operation during the follow-up were observed. The median survival period was 7.40 months (95%CI 6.204 - 8.596) and the mean survival period was 8.03 months (95%CI 6.142 - 9.909). Development of a new biliary intraluminal irradiation stent system loaded with (125)I seeds is technically feasible and safe, treatment of this stent system has potential benefits of extending survival, however the long-term clinical efficacy needs to be certificated by further follow-up observation and control trials.