Abstract
To evaluate the safety and efficacy of self-expandable metallic stent placement combined with or without intraluminal 125I seed strands brachytherapy in patients with malignant biliary obstruction. Participants were randomly assigned to receive treatment with a self-expandable metallic stent (SEMS) placement combined with intraluminal 125I seed strands brachytherapy (brachytherapy group) or a SEMS without brachytherapy (control group). The outcomes were measured in terms of technical success, clinical success, stent patency, complications related to the procedure, and patient survival. A P value of less than 0.05 indicated a significant difference. Results There were no significant differences in technical and clinical success between brachytherapy and control group (100 vs. 100%-100 vs. 93.3%). During the median 273.4 ± 154.6 days follow-up time, the median stent patency time in the brachytherapy group was longer than those in the control group (368.0 ± 42.4 vs. 220.0 ± 34.8 days), and the duration of survival in the brachytherapy groups was higher than those in the control group (355.0 ± 71.5 vs. 209.0 ± 17.2 days). There were no significant differences in the complications between the two groups. Conclusions SEMS placement combined with intraluminal 125I seed strands brachytherapy are feasible and effective for malignant biliary obstruction, and seems to prolong the stent patency and survival time.
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