A Comparative Study of Self-Expandable Metallic Stent Combined with Double (125)I Seeds Strands or Single (125)I Seeds Strand in the Treatment of Advanced Perihilar Cholangiocarcinoma with Malignant Obstructive Jaundice

PURPOSE: The purpose of this study was to compare the safety and effectiveness of a self-expandable metallic stent (SEMs) with a novel brachytherapy biliary drainage catheter (BBDC, double (125)I seeds strands) or a single (125)I seeds strand in the treatment of advanced perihilar cholangiocarcinoma (pCCA) with malignant obstructive jaundice (MOJ). METHODS: From September 2016 to December 2018, we retrospectively enrolled patients with biliary stent implantation after receiving either BBDC loaded with (125)I seeds (double-strands irradiation group) or an (125)I seed strand treatment (single-strand irradiation group, control group). The outcomes were analyzed regarding the relief of obstructive jaundice, and interventional-related complications. Moreover, the Kaplan–Meier method was used to analyze stent patency and survival. RESULTS: The success rate of interventional therapy in both groups was 100%, and all patients with MOJ were alleviated. According to the Common Terminology Criteria for Adverse Events (CTCAE 4.02), the grade 3 or 4 complications in the BBDC group and in the control group were 6/34 (17.65%) and 7/39 (17.95%), respectively (P > 0.05). The median and mean overall stent patency of the BBDC group and the control group were 207 days versus 180 days, 204.212 days versus 186.278 days (P = 0.043). The median and mean overall survivals in the BBDC group were higher than those in the control group (245 days versus 212 days, 244.883 days versus 221.844 days, P = 0.030). CONCLUSION: This interim analysis showed that BBDC (double-stranded irradiation) can prolong the stent patency time compared with (125)I seed strand treatment (single-stranded irradiation) and had the advantage of reducing jaundice, which seemed to extend the survival period of advanced pCCA.