Wei Chen1, Xiang-Ming Fang2, Xuan Wang1, Sanjeev Kumar Pitla Sudarshan3, Xiao-Yun Hu2, Hong-Wei Chen2. 1. Department of Intervention Radiology, Huai'an First People's Hospital, Nanjing Medical University, Huai'an, Jiangsu Province, China. 2. Imaging Center, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, Jiangsu Province, China. 3. Department of Medical Imaging, Parexel international PVT LTD, Musheerabad, Hyderabad, Telangana, India.
Abstract
PURPOSE: To evaluate the clinical efficacy of percutaneous trans-hepatic integrated 125I seed stents implantation for malignant lower biliary tract obstruction. METHODS:Thirty-two patients with malignant lower biliary obstruction were randomly divided into two groups. One group underwent the therapy with integrated 125I seed stents (Test group, n = 13), and another group received conventional metal stents implantation for treatment (Control group, n = 19). The pre- and post-operative changes in biochemical indices, white blood cell count, IgG level, stent patency, survival time, tumor size and complications were compared between the two groups. RECIST 1.1 (Response Evaluation Criteria In Solid Tumors) was used to evaluate therapeutic effects. The average follow-up time was 12.3 months. RESULTS: The differences between pre- and post-operative (30 days) intragroup biochemical indices had statistically significant difference (P < 0.05), but there were no significant differences (P > 0.05) in leukocyte counts and IgG levels. As to the median time of stent patency and patients' survival, there were significant differences (P < 0.05) between Control and Test groups (3.9 months vs. 8.1 months, 139 days vs. 298 days, respectively). Three months after the operation, the average tumor size was reduced in the Test group, but was increased in the Control group (P < 0.05). There was no significant difference in the incidence of complications between the two groups. The evaluation results using RECIST 1.1 showed that there were statistically significant differences between the two groups in terms of the rates of remission, control, and progression (χ2 = 17.5, P < 0.05). CONCLUSIONS: The study indicates that integrated 125I seed stents are effective in reducing jaundice symptoms, inhibiting tumor growth, improving stent patency and prolonging patient survival, which may serve as a safer and more feasible method in treating malignant lower biliary obstruction with minimal invasiveness.
RCT Entities:
PURPOSE: To evaluate the clinical efficacy of percutaneous trans-hepatic integrated 125I seed stents implantation for malignant lower biliary tract obstruction. METHODS: Thirty-two patients with malignant lower biliary obstruction were randomly divided into two groups. One group underwent the therapy with integrated 125I seed stents (Test group, n = 13), and another group received conventional metal stents implantation for treatment (Control group, n = 19). The pre- and post-operative changes in biochemical indices, white blood cell count, IgG level, stent patency, survival time, tumor size and complications were compared between the two groups. RECIST 1.1 (Response Evaluation Criteria In Solid Tumors) was used to evaluate therapeutic effects. The average follow-up time was 12.3 months. RESULTS: The differences between pre- and post-operative (30 days) intragroup biochemical indices had statistically significant difference (P < 0.05), but there were no significant differences (P > 0.05) in leukocyte counts and IgG levels. As to the median time of stent patency and patients' survival, there were significant differences (P < 0.05) between Control and Test groups (3.9 months vs. 8.1 months, 139 days vs. 298 days, respectively). Three months after the operation, the average tumor size was reduced in the Test group, but was increased in the Control group (P < 0.05). There was no significant difference in the incidence of complications between the two groups. The evaluation results using RECIST 1.1 showed that there were statistically significant differences between the two groups in terms of the rates of remission, control, and progression (χ2 = 17.5, P < 0.05). CONCLUSIONS: The study indicates that integrated 125I seed stents are effective in reducing jaundice symptoms, inhibiting tumor growth, improving stent patency and prolonging patient survival, which may serve as a safer and more feasible method in treating malignant lower biliary obstruction with minimal invasiveness.