胆管内照射支架的研制及临床应用的初步结果

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

目的探讨胆管内照射支架研制、临床使用的可行性、安全性及初步疗效。方法经本院医学伦理委员会许可，术前履行告知义务并获得同意后，对临床诊断明确的恶性胆管梗阻患者进行内照射支架置入术。收集2008年11月至2009年11月东南大学附属中大医院12例恶性胆管梗阻患者，采用经皮肝内胆管穿刺方法，将外支架和与之匹配的内支架先后置人至病变部位并使两者套叠，术后进行临床随访。结果12例患者胆管内照射支架均释放到位，释放过程顺利，释放过程中未出现放射粒子脱落现象；全身ECT复查未发现放射源泄漏；术后患者阻黄症状得到明显改善，血象和免疫指标亦未见明显变化，未出现如胆管穿孔、出血等并发症；其中位生存期7．40个月，平均生存期8．03个月。结论胆管内照射支架系统临床使用是可行、安全、有效的，其临床长期疗效需进一步随访观察及对照研究。

Objective To evaluate the feasibility, safety and efficiency of a new biliary intraluminal irradiation stent system loaded with ^125I seeds. Methods 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 ^125I 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. Results The whole biliary stent systems loaded with ~25I seeds were successfully placed in 12 patients, no ^125I 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）. Conclusion Development of a new billary intraluminal irradiation stent system loaded with ^125I 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.