Iodine-125 Seeds Combined With Biliary Stent Placement Versus Stent Placement Alone For Unresectable Malignant Biliary Obstruction: A Meta-Analysis Of Randomized Controlled Trials

Abstract

<b>Background and Aims:</b> Malignant biliary obstruction is always caused by tumors which are unresectable so that palliative stent placement is conducted for drainage of bile duct tree. Recently, irradiation stent with ¹²⁵I seeds has been used to improve the stent patency and survival time of patients. We conducted this meta-analysis to evaluate the therapeutic efficacy and safety of biliary stent placement with ¹²⁵I seeds compared with stent placement alone in patients with malignant biliary obstruction. <b>Methods:</b> We searched Pubmed, Web of Science, ClinicalTrials.gov, Cochrane Library, Embase and CNKI databases for all relevant studies up to 1 May 2020. Patient survival, stent patency, and adverse events were the primary outcome measured. Also, Review Manager 5.3 and Stata/SE15.0 were used to perform the analysis. <b>Results:</b> Eleven randomized controlled trials with a total of 767 patients were included for meta-analysis. Stent combined with ¹²⁵I seeds showed lower risk of stent occlusion at 3 month (Odds Ratios(OR) = 0.15; 95%CI: 0.05-0.49, <i>P</i> =0.002), 6 month (OR = 0.18; 95%CI: 0.08-0.44, <i>P</i> = 0.0001), 9 month (OR = 0.10; 95%CI: 0.05-0.20, <i>P</i> < 0.00001) and 1 year (OR = 0.15; 95%CI: 0.07-0.31, <i>P</i> < 0.00001) and better mean survival (MD = 125days; 95% CI 91-159 days; P < 0.00001) compared with stent placement alone. Also, reconstructed Kaplan-Meier data demonstrated improved survival in patients treated with stent plus ¹²⁵I seeds (hazard ratio(HR)= 1.886; 95% CI: 1.609 to 2.210; P < 0.0001) Moreover, our analysis did not show significant difference between the two groups about the risk of adverse events including abdominal pain, hemobilia, pancreatitis, cholangitis and cholecystitis. <b>Conclusion:</b> ¹²⁵I seeds combined with stent demonstrated superior stent patency and improved survival time compared to stent alone with acceptable complications.