A newly designed biliary brachytherapy drainage catheter for patients with malignant biliary obstruction: A pilot study

Aim: Self-expandable metallic stent (SEMS) placement has been considered as the preferred treatment to relieve jaundice in nonsurgical patients. However, 50% of stents become stenosed within 3-6 months due to tumor ingrowth and epithelial hyperplasia. This study aims to evaluate the feasibility and efficacy of a newly designed brachytherapy biliary drainage catheter (BBDC) loaded with I-125 seeds for palliation of malignant biliary obstruction (MBO). Methods: In this prospective study, patients with unresectable MBO underwent BBDC placement after SEMS placement at our center from September 2017 to April 2019. Results: A total of 21 patients with MBO were enrolled. The technical and clinical success rates were 100%. Total bilirubin, direct bilirubin, alanine aminotransferase, alkaline phosphatase, cancer antigen 19-9, and carcinoembryonic antigen levels significantly decreased during the 1-month follow-up (P < 0.05). Four patients (19%) had minor complications. During the median follow-up of 299 days, 13 patients (61.9%) developed stent occlusion. The 6-month stent patency and survival rates were 73.5% and 79.2%, respectively. The median stent patency and survival were 279 and 454 days, respectively. Conclusion: The use of BBDC loaded with I-125 seeds is a feasible and effective method to prolong biliary stent patency in patients with MBO.