The efficacy and safety of biliary stenting alone versus stenting combined with iodine-125 seed strand implantation for the treatment of cholangiocarcinoma with malignant obstructive jaundice: a prospective, nonrandomized, controlled clinical study

Abstract

Background: Many patients with cholangiocarcinoma also present with malignant obstructive jaundice (MOJ), which requires biliary drainage and stent placement. Recently, clinicians have tried to implant iodine-125 seeds into the biliary tract. However, we know very little about this treatment. This study aimed to compare biliary stenting alone and stenting combined with iodine-125 seed strand implantation to evaluate the safety and efficacy of this technique.

Methods: Sixty patients of cholangiocarcinoma with MOJ were enrolled into the study. According to voluntary choices, 30 received biliary stenting combined with iodine-125 seed strand implantation (study group), and 30 received biliary stent implantation alone (control group). Various biochemical indicators and the manifestation of computed tomography (CT) or magnetic resonance imaging (MRI) were compared before and after operation. We evaluated the safety and efficacy of these treatments by observing patients' symptoms, biochemical indicators and imaging data. Individualized antitumor therapy and regular follow-up were given according to the patients' condition.

Results: All 60 patients successfully completed operation. There were no statistically significant differences in baseline data between two groups (P>0.05). Before and 4 weeks after operation, the average total bilirubin levels decreased from 268.14±114.97 to 54.00±80.78 µmol/L in study group, and decreased from 228.89±162.04 to 58.80±61.14 µmol/L in control group. The difference between two groups was not statistically significant (P=0.796). Before and 4 weeks after operation, the average Child-Pugh scores decreased from 7.83±0.59 to 6.20±1.03 points in study group, and decreased from 7.93±1.08 to 7.07±1.39 points in control group, with a statistically significant difference between two groups (P=0.008). The median patency time of stents was 41.71±3.46 weeks in study group and 29.00±5.81 weeks in control group, with a statistically significant difference between the two groups (P=0.037). A statistically significant difference in disease control rate (DCR) was observed between the two groups (P=0.045).

Conclusions: This study demonstrated biliary stenting combined with iodine-125 seed strand implantation may be consider as a safe treatment option for the patients of cholangiocarcinoma with MOJ, and this treatment may improve liver function, reduce the incidence of in-stent restenosis, and improve DCR.

Keywords: Biliary tract malignancy; biliary stent; brachytherapy; iodine-125 seed; jaundice.