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

Background and Aims: 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 (125)I 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( 125)I seeds compared with stent placement alone in patients with malignant biliary obstruction. Methods: 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. Results: Eleven randomized controlled trials with a total of 767 patients were included for meta-analysis. Stent combined with (125)I seeds showed lower risk of stent occlusion at 3 month (Odds Ratios(OR) = 0.15; 95%CI: 0.05-0.49, P =0.002), 6 month (OR = 0.18; 95%CI: 0.08-0.44, P = 0.0001), 9 month (OR = 0.10; 95%CI: 0.05-0.20, P < 0.00001) and 1 year (OR = 0.15; 95%CI: 0.07-0.31, P < 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 (125)I 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. Conclusion: (125)I seeds combined with stent demonstrated superior stent patency and improved survival time compared to stent alone with acceptable complications.