The Effect of HVPG-Guided Individualized Therapy in Patients With Cirrhosis Related Esophagogastric Variceal Hemorrhage For Secondary Prophylaxis:A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mortality rate
研究概览
简要总结
The purpose of the study is to compare the effect of HVPG-guided individualized therapy and non-HVPG guided traditional therapy in cirrhotic patients for secondary prophylaxis.
详细描述
The study is a randomized controlled trial of Zelen-design. Patients randomly enter two treatment groups: 1) the HVPG group and 2) the non-HVPG group. Treatment allocation is by block randomization with an equal number for both groups. The results are concealed in opaque envelopes.After randomization, patients will have a second chance to decide if they want to stay in the current group.Patients can switch to another group according to their will. If they are in the HVPG group，they will receive HVPG measurement before treatment. If they are in the non-HVPG group, they start treatment without HVPG measurement and receive endoscopic treatment plus Carvedilol.The mortality rate and rebleeding rate will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices;
- •Patients with a previous history of variceal hemorrhage;
- •Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018
排除标准
- •Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies;
- •Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival;
- •Patients in pregnancy and lactation;
- •Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors;
- •Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis;
- •Patients with conditions that will influence the accuracy of HVPG measurement: Cavernous transformation of portal vein, diffused portal vein thrombosis, severe shunt;
- •Patients refuse to give consent to the study.
研究组 & 干预措施
HVPG group
HVPG-guided therapy
干预措施: HVPG-guided therapy (Procedure)
HVPG group
HVPG-guided therapy
干预措施: Carvedilol (Drug)
non-HVPG group
routine therapy
干预措施: routine therapy (Other)
non-HVPG group
routine therapy
干预措施: Carvedilol (Drug)
结局指标
主要结局
Mortality rate
时间窗: through study completion, an average of 1 year
The investigators observe the mortality events in both groups during the study
次要结局
- Rebleeding rate(through study completion, an average of 1 year)
- Adverse Events(through study completion, an average of 1 year)
- Total cost(through study completion, an average of 1 year)
研究者
Shiyao Chen
Director of department of Gastroenterology, Zhongshan Hospital
Shanghai Zhongshan Hospital