Study of self-expandable metallic stent placement intraluminal 125 I seed strands brachytherapy of malignant biliary obstruction.

OBJECTIVE: To evaluate the safety and efficacy of self-expandable metallic stent placement combined with or without intraluminal 125 I seed strands brachytherapy in patients with malignant biliary obstruction.

METHODS: Participants were randomly assigned to receive treatment with a self-expandable metallic stent (SEMS) placement combined with intraluminal 125 I 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 125 I seed strands brachytherapy are feasible and effective for malignant biliary obstruction, and seems to prolong the stent patency and survival time.