title: A novel biliary stent loaded with (125)I seeds in patients with malignant biliary obstruction: preliminary results versus a conventional biliary stent.
abstract: OBJECTIVE
  Stenting is a palliative therapy method for relieving malignant biliary obstruction. The aim of this study was to evaluate the safety and effectiveness of an irradiation stent compared to a conventional biliary stent in patients with biliary obstruction caused by both primary and metastatic adenocarcinomas.
  
  
  METHODS
  Participants were randomly assigned to receive treatment with a biliary irradiation stent (irradiation stent group) or a conventional biliary stent (control group). After stent implantation, the outcomes were measured in terms of relief of obstructive jaundice, survival time, complications related to the procedure. A p value of less than 0.05 indicated a significant difference.
  
  
  RESULTS
  The stents were successfully placed in all the 23 patients. The obstructive jaundice was relieved in all patients except three in the control group. The median and mean overall survivals in the irradiation stent group were higher than those in the control group (7.40 months versus 2.50 months, 8.03 months versus 3.36 months, p=0.006). The patients with stent patent at 3, 6, and 12 months in the irradiation stent group were 11 (91.7%), 7 (58.3%), and 1 (8.3%), respectively. While in the control group, 4 (36.4%), 1 (9.1%), and 0 (0%), respectively. There were no significant differences in the complications related to stent insertion between the two groups.
  
  
  CONCLUSIONS
  This interim analysis shows that treatment with the biliary intraluminal irradiation stent in patients with biliary obstruction caused by adenocarcinomas appears safe and technically feasible, has benefits in relieving jaundice, and seems to extend survival when compared to a conventional biliary stent.
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Hai-Dong
authors.initials: HD
authors.lastname: Zhu
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Jin-He
authors.initials: JH
authors.lastname: Guo
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Guang-Yu
authors.initials: GY
authors.lastname: Zhu
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Shi-Cheng
authors.initials: SC
authors.lastname: He
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Fang
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Deng
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Yong-Lin
authors.initials: YL
authors.lastname: Qin
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.
authors.forename: Guo-Zhao
authors.initials: GZ
authors.lastname: Li
authors.affiliation: Department of Radiology, University of Louisville Hospital, 530 South Jackson Street, Louisville, KY 40202, USA.
authors.forename: Douglas M
authors.initials: DM
authors.lastname: Coldwell
authors.affiliation: Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China. Electronic address: gjteng@vip.sina.com.
authors.forename: Gao-Jun
authors.initials: GJ
authors.lastname: Teng
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000401:mortality / Q000532:radiotherapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000150:complications / Q000401:mortality / Q000532:radiotherapy*; D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007457:Iodine Radioisotopes / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011878:Radiotherapy / Q000379:methods*; D012189:Retrospective Studies; D016037:Single-Blind Method; D015607:Stents / Q000009:adverse effects; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D007457:Iodine Radioisotopes