Endoscopic Treatment vs Transjugular Intrahepatic Portosystemic Shunt in the Management of Oxaliplatin Related Gastroesophageal Variceal Bleeding: A Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 24-week re-bleeding
研究概览
简要总结
In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
详细描述
Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having received oxaliplatin-based chemotherapy for at least one cycle
- •History of variceal bleeding (including hematemesis or melena)
- •Portal hypertension confirmed by CT or MRI
- •Esophageal and / or gastric varices confirmed by endoscopy
- •Informed consent signed
排除标准
- •With serious life-threatening diseases of circulation / blood / respiratory system
- •With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.)
- •With contraindications of endoscopic treatments and TIPS;
- •Participation refused
结局指标
主要结局
24-week re-bleeding
时间窗: 24 weeks
Hematemesis ,melena, or hemoglobin level decreased by 10 g/L within 6 hours
次要结局
- 8-week adverse events(8 weeks)
- 24-week mortality(24 weeks)
- 8-week mortality(8 weeks)
- 24-week adverse events(24 weeks)
- 8-week re-bleeding(8 weeks)
研究者
Shiyao Chen
Professor
Shanghai Zhongshan Hospital