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 125I 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 125I seeds is a feasible and effective method to prolong biliary stent patency in patients with MBO.