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Purpose: To develop, validate, and compare early warning models of the 30-day mortality risk for patients with malignant biliary obstruction (MBO) undergoing percutaneous transhepatic biliary stent placement (PTBS)., Materials and Methods: Between January 2013 and October 2018, this multicenter retrospective study included 299 patients with MBOs who underwent PTBS. The training set consisted of 166 patients from four cohorts, and another two independent cohorts were allocated as external validation sets A and B with 75 patients and 58 patients, respectively. A logistic model and an artificial neural network (ANN) model were developed to predict the risk of 30-day mortality after PTBS. The predictive performance of these two models was validated internally and externally., Results: The ANN model had higher values of area under the curve than the logistic model in the training set (0.819 vs 0.797), especially in the validation sets A (0.802 vs 0.714) and B (0.732 vs 0.568). Both models had high accuracy in the three sets (75.9-83.1%). Along with a high specificity, the ANN model improved the sensitivity. The net reclassification improvement and integrated discrimination improvement also demonstrated that the ANN model led to improvements in predictive ability compared with the logistic model., Conclusions: Early warning models were proposed to predict the risk of 30-day mortality after PTBS in patients with MBO. The ANN model has higher accuracy and better generalizability than the logistic model.

Purpose: To establish a nomogram for predicting the occurrence of early biliary infection (EBI) after percutaneous transhepatic biliary stent (PTBS) placement in malignant biliary obstruction (MBO)., Materials and Methods: In this multicenter study, patients treated with PTBS for MBO were allocated to a training cohort or a validation cohort. The independent risk factors for EBI selected by multivariate analyses in the training cohort were used to develop a predictive nomogram. An artificial neural network was applied to assess the importance of these factors in predicting EBI. The predictive accuracy of this nomogram was determined by concordance index (c-index) and a calibration plot, both internally and externally., Results: A total of 243 patients (training cohort: n = 182; validation cohort: n = 61) were included in this study. The independent risk factors were length of obstruction (odds ratio [OR], 1.061; 95% confidence interval [CI], 1.013-1.111; P = .012), diabetes (OR, 5.070; 95% CI, 1.917-13.412; P = .001), location of obstruction (OR, 2.283; 95% CI, 1.012-5.149; P = .047), and previous surgical or endoscopic intervention (OR, 3.968; 95% CI, 1.709-9.217; P = .001), which were selected into the nomogram. The c-index values showed good predictive performance in the training and validation cohorts (0.792 and 0.802, respectively). The optimum cutoff value of risk was 0.25., Conclusions: The nomogram can facilitate the early and accurate prediction of EBI in patients with MBO who underwent PTBS. Patients with high risk (> 0.25) should be administered more effective prophylactic antibiotics and undergo closer monitoring., (Copyright © 2019 SIR. Published by Elsevier Inc. All rights reserved.)

Background & Aims: Placement of an irradiation stent has been demonstrated to offer longer patency and survival than an uncovered self-expandable metallic stent (SEMS) in patients with unresectable malignant biliary obstruction (MBO). We aim to further assess the efficacy of an irradiation stent compared to an uncovered SEMS in those patients., Methods: We performed a randomized, open-label trial of participants with unresectable MBO at 20 centers in China. A total of 328 participants were allocated in parallel to the irradiation stent group (ISG) or the uncovered SEMS group (USG). Endpoints included stent patency (primary), technical success, relief of jaundice, overall survival, and complications., Results: The first quartile stent patency time (when 25% of the patients experienced stent restenosis) was 212 days for the ISG and 104 days for the USG. Irradiation stents were significantly associated with a decrease in the rate of stent restenosis (9% vs. 15% at 90 days; 16% vs. 27% at 180 days; 21% vs. 33% at 360 days; p = 0.010). Patients in the ISG obtained longer survival time (median 202 days vs. 140 days; p = 0.020). No significant results were observed in technical success rate (93% vs. 95%; p = 0.499), relief of jaundice (85% vs. 80%; p = 0.308), and the incidence of grade 3 and 4 complications (8.5% vs. 7.9%; p = 0.841)., Conclusions: Insertion of irradiation stents instead of uncovered SEMS could improve patency and overall survival in patients with unresectable MBO., Lay Summary: For patients with unresectable malignant biliary obstruction (MBO), placement of a self-expandable metallic stent (SEMS) is a recommended palliative modality to relieve pruritus, cholangitis, pain, and jaundice. However, restenosis is a main pitfall after stent placement. Data from this first multicenter randomized controlled trial showed that insertion of an irradiation stent provided longer patency and better survival than a conventional metal stent. ClinicalTrials.gov ID: NCT02001779., (Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Background & Aims: Stenting is a palliative therapy method for relieving malignant biliary obstruction. The aim of this study was to evaluate the safety and effectiveness of an irradiation stent compared to a conventional biliary stent in patients with biliary obstruction caused by both primary and metastatic adenocarcinomas., Methods: Participants were randomly assigned to receive treatment with a biliary irradiation stent (irradiation stent group) or a conventional biliary stent (control group). After stent implantation, the outcomes were measured in terms of relief of obstructive jaundice, survival time, complications related to the procedure. A p value of less than 0.05 indicated a significant difference., Results: The stents were successfully placed in all the 23 patients. The obstructive jaundice was relieved in all patients except three in the control group. The median and mean overall survivals in the irradiation stent group were higher than those in the control group (7.40 months versus 2.50 months, 8.03 months versus 3.36 months, p=0.006). The patients with stent patent at 3, 6, and 12 months in the irradiation stent group were 11 (91.7%), 7 (58.3%), and 1 (8.3%), respectively. While in the control group, 4 (36.4%), 1 (9.1%), and 0 (0%), respectively. There were no significant differences in the complications related to stent insertion between the two groups., Conclusions: This interim analysis shows that treatment with the biliary intraluminal irradiation stent in patients with biliary obstruction caused by adenocarcinomas appears safe and technically feasible, has benefits in relieving jaundice, and seems to extend survival when compared to a conventional biliary stent., (Copyright © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Objective: To evaluate the feasibility, safety and efficiency of a new biliary intraluminal irradiation stent system loaded with (125)I seeds., Methods: The study was approved by the institutional ethics committee of our hospital, and informed consent was obtained from each patient. Patients with malignant biliary obstruction were treated with a new biliary irradiation stent system loaded with (125)I seeds according to a treatment plan system. All of the biliary seeds carrying devices combined with the matched biliary stents were placed by the procedures of percutaneous transhepatic biliary puncture. After stents implantation, all patients were followed-up., Results: The whole biliary stent systems loaded with (125)I seeds were successfully placed in 12 patients, no (125)I seeds exfoliation during the procedure and no radioactive leakage by general emission computed tomography reexamination during the follow-up were observed. The obstructive jaundice relived and the systemic conditions improved remarkably in all patients. There were no complications related to the stents, such as biliary perforation or hemobilia, were observed. And no significant change in the blood routine and immune parameters detected before and after operation during the follow-up were observed. The median survival period was 7.40 months (95%CI 6.204 - 8.596) and the mean survival period was 8.03 months (95%CI 6.142 - 9.909)., Conclusion: Development of a new biliary intraluminal irradiation stent system loaded with (125)I seeds is technically feasible and safe, treatment of this stent system has potential benefits of extending survival, however the long-term clinical efficacy needs to be certificated by further follow-up observation and control trials.