Hai-Dong Zhu1, Jin-He Guo1, Ming Huang2, Jian-Song Ji3, Hao Xu4, Jian Lu1, Hai-Liang Li5, Wen-Hui Wang6, Yu-Liang Li7, Cai-Fang Ni8, Hai-Bin Shi9, En-Hua Xiao10, Wei-Fu Lv11, Jun-Hui Sun12, Ke Xu13, Guo-Hong Han14, Lin-An Du15, Wei-Xin Ren16, Mao-Quan Li17, Ai-Wu Mao18, Hua Xiang19, Kai-Xian Zhang20, Jie Min21, Guang-Yu Zhu1, Chang Su22, Li Chen1, Gao-Jun Teng23. 1. Department of Radiology, Zhongda Hospital, Southeast University, Nanjing 210009, China. 2. Department of Minimally Invasive Interventional Radiology, Yunnan Tumor Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming 650106, China. 3. Department of Radiology, Lishui Central Hospital, Wenzhou Medical University, Lishui 323000, China. 4. Department of Interventional Radiology, Affiliated Hospital of Xuzhou Medical University, Xuzhou 221002, China. 5. Department of Intervention Radiology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China. 6. Department of Interventional Radiology, the First Hospital, Lanzhou University, Lanzhou 730000, China. 7. Department of Interventional Medicine, the Second Hospital of Shandong University, Jinan 250033, China. 8. Department of Interventional Radiology, First Affiliated Hospital of Soochow University, Suzhou 215006, China. 9. Department of Radiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China. 10. Department of Radiology, the Second Xiangya Hospital, Central South University, Changsha 410011, China. 11. Department of Radiology, Affiliated Anhui Provincial Hospital of Anhui Medical University, Hefei 230001, China. 12. Hepatobiliary and Pancreatic Interventional Treatment Center, Division of Hepatobiliary and Pancreatic Surgery, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China. 13. Department of Radiology, the First Affiliated Hospital of China Medical University, Shenyang 110001, China. 14. Department of Liver Disease and Digestive Interventional Radiology, Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China. 15. Department of Interventional Radiology, the Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China. 16. Department of Interventional Radiology, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China. 17. Department of Interventional and Vascular Surgery, Shanghai 10th People's Hospital, Tongji University, Shanghai 200072, China. 18. Department of Interventional Radiology, Shanghai St. Luke's Hospital, Shanghai 200050, China. 19. Department of Interventional Radiology and Vascular Surgery, Hunan Provincial People's Hospital, Changsha 410005, China. 20. Department of Oncology, Teng Zhou Central People's Hospital Affiliated to Jining Medical University, Teng Zhou 277599, China. 21. Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing 210009, China. 22. Clinical Research Institute, Zhongda Hospital, Medical School, Southeast University, Nanjing 210009, China. 23. Department of Radiology, Zhongda Hospital, Southeast University, Nanjing 210009, China. Electronic address: gjteng@vip.sina.com.
Abstract
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.
RCT Entities:
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.