Asihaer Hasimu1, Jun-Peng Gu1, Wei-Zheng Ji1, Hai-Xiao Zhang1, Di-Wen Zhu1, Wei-Xin Ren2. 1. Department of Radiology, The First Affiliated Hospital of XinJiang Medical University, Urumqi, XinJiang830054, China. 2. Department of Radiology, The First Affiliated Hospital of XinJiang Medical University, Urumqi, XinJiang830054, China. Electronic address: rwx1031@163.com.
Abstract
PURPOSE: To prospectively evaluate safety and efficacy of biliary stent placement with iodine-125 (125I) seeds in patients with malignant obstructive jaundice (MOJ). MATERIALS AND METHODS:From July 2011 to June 2014, 55 patients were enrolled (group A, 11 men and 17 women, mean age 70.93 y ± 8.58; group B, 14 men and 13 women, mean age 70.26 y ± 9.71). All patients were randomly assigned to placement of a biliary stent with 125I seeds (group A) or biliary stent only (group B). After stent placement, outcomes were measured regarding relief of MOJ. Clinical success rate, survival time, and safety were recorded. P < .05 was considered to indicate significant difference. RESULTS: Stents were successfully placed in all 55 patients. MOJ was relieved in all patients, and there were no significant differences in complications related to stent insertion between the 2 groups. Mean and median stent patency were 191 days ± 19.8 (95% confidence interval [CI], 152-230 d) and 179 days ± 191.4 (95% CI, 87-267 d) in group A and 88.3 days ± 16.3 (95% CI, 61-114 d) and 77 days ± 88.2 (95% CI, 65-86 d) in group B (P < .001, log-rank test). Mean and median survival time were 222.6 days ± 21.0 (95% CI, 181-263 d) and 241 days ± 18.2 (95% CI, 179-270 d) in group A and 139.1 days ± 14.5 (95% CI, 110-167 d) and 142 days ± 16.3 (95% CI, 83-177 d) in group B (P < .001, log-rank test). CONCLUSIONS: 125I seeds combined with biliary stent placement could significantly improve stent patency. The procedure seems to be safe and to extend survival compared with self-expandable biliary stent placement.
RCT Entities:
PURPOSE: To prospectively evaluate safety and efficacy of biliary stent placement with iodine-125 (125I) seeds in patients with malignant obstructive jaundice (MOJ). MATERIALS AND METHODS: From July 2011 to June 2014, 55 patients were enrolled (group A, 11 men and 17 women, mean age 70.93 y ± 8.58; group B, 14 men and 13 women, mean age 70.26 y ± 9.71). All patients were randomly assigned to placement of a biliary stent with 125I seeds (group A) or biliary stent only (group B). After stent placement, outcomes were measured regarding relief of MOJ. Clinical success rate, survival time, and safety were recorded. P < .05 was considered to indicate significant difference. RESULTS: Stents were successfully placed in all 55 patients. MOJ was relieved in all patients, and there were no significant differences in complications related to stent insertion between the 2 groups. Mean and median stent patency were 191 days ± 19.8 (95% confidence interval [CI], 152-230 d) and 179 days ± 191.4 (95% CI, 87-267 d) in group A and 88.3 days ± 16.3 (95% CI, 61-114 d) and 77 days ± 88.2 (95% CI, 65-86 d) in group B (P < .001, log-rank test). Mean and median survival time were 222.6 days ± 21.0 (95% CI, 181-263 d) and 241 days ± 18.2 (95% CI, 179-270 d) in group A and 139.1 days ± 14.5 (95% CI, 110-167 d) and 142 days ± 16.3 (95% CI, 83-177 d) in group B (P < .001, log-rank test). CONCLUSIONS: 125I seeds combined with biliary stent placement could significantly improve stent patency. The procedure seems to be safe and to extend survival compared with self-expandable biliary stent placement.
Authors: Shuai Zhou; Chao Zhu; Shi Lei Chen; Jin Ang Li; Kang Lin Qu; Hao Jing; Yong Wang; Qing Pang; Hui Chun Liu Journal: Int J Gen Med Date: 2021-06-18