Evaluation of stent placement for vena cava syndrome: phase II trial and phase III randomized controlled trial
Evaluation of stent placement for vena cava syndrome: phase II trial and phase III randomized controlled trial
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DOI：
10.1007/s00520-018-4397-5
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发表时间：
2019-03-01
影响因子：
3.1
通讯作者：
Kobayashi, Takeshi
中科院分区：
文献类型：
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作者：
Takeuchi, Yoshito;Arai, Yasuaki;Kobayashi, Takeshi
目的恶性肿瘤压迫上级腔静脉或下腔静脉引起的腔静脉综合征（Vena cava syndrome，VNS）是晚期恶性肿瘤患者的典型临床表现之一。糖尿病很难治疗，而且很痛苦，降低了患者的生活质量。尽管有几篇报道研究了支架置入术治疗腰椎间盘突出症，但由于缺乏安全性和有效性的证据，这种治疗从未被确立为标准。我们进行了第二阶段的试验和第三阶段的随机对照试验，以澄清支架置入术在管理患者的cardiovascular.MethodsIn第二阶段的试验，28名符合条件的患者进行了治疗与支架置入术的作用。根据治疗后14天内患者症状评分的降低情况评价支架置入术治疗冠心病的疗效。评估技术成功率、技术可行性、总生存率、症状复发率和不良事件。在III期试验中，32例患者入组并随机分配至试验组（n=16）和对照组（n=16）。比较两组症状评分曲线下面积。EQ-5D，SF-8，和不良事件进行评估，直到停止协议治疗或28 days后enrolling.ResultsIn第II期试验，中位患者的症状评分显着下降，从10.50前的程序到3.00后的程序。技术成功率和技术可行性率分别为96.4%和100%。治疗相关3级或以上不良事件的发生率为14.3%。在III期试验中，与对照组相比，试验组的支架置入具有显著的优效性。结论支架置入术可明显改善血管紧张素Ⅱ的症状，可作为血管紧张素Ⅱ的标准治疗方法。试验注册号：JIVROSG-0402，JIVROSG-0807
PurposeVena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS.MethodsIn the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n=16) and control groups (n=16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28days after enrollment.ResultsIn the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.ConclusionsStent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS.Trial registration: JIVROSG-0402, JIVROSG-0807