The Influence of Shunting Left/Right Portal Vein Branch on Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The incidence of HE
研究概览
简要总结
Through a multicenter randomized controlled trial of TIPS to prevent post-hepatitis B cirrhosis of esophagogastric varices, the incidence of hepatic encephalopathy, the rate of stent patency, the incidence of rebleeding and survival in the left and right branches of the portal vein were compared.
详细描述
The most common cause of cirrhosis in China is hepatitis B virus infection; post-hepatitis B cirrhosis with gastroesophageal variceal hemorrhage is common in clinical practice; recent studies [14] found that implantation of 8 mm diameter is compared with the use of 10 mm diameter stents. The membrane stent significantly reduced the incidence of HE after TIPS without affecting the shunt effect. To further evaluate the effect of "left/right branch of shunt portal" on hepatic encephalopathy after TIPS, we intend to conduct the following studies: for individual etiology (post-hepatitis B cirrhosis), the only indication (to prevent recurrent rupture of gastroesophageal varices) ), implanted 8mm diameter Viatorr stent, unified HE evaluation criteria, and stratified multi-center randomized clinical trial study with Child classification, hope to guide TIPS in line with China's national conditions through the high-level evidence-based medical evidence obtained.
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 (Participant)
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
- •The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old;
- •Clinically diagnosed post-hepatitis B cirrhosis;
- •History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment;
- •Liver function Child A or B;
- •Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic portal can construct a shunt;
- •Platelet count ≥ 50 × 109 / L;
- •Prothrombin time (PT) does not exceed the upper limit of the normal control for 3 seconds;
- •Serum creatinine concentration ≤115umol/L;
- •Patients and their families agree to join the clinical trial and sign an informed consent form.
排除标准
- •Imaging confirms portal vein thrombosis;
- •Patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt);
- •Combine any malignant tumor;
- •History of previous hepatic encephalopathy;
- •Consolidation of intractable ascites;
- •Pulmonary artery pressure > 40 mmHg, left ventricular ejection fraction < 50%, congestive heart failure or severe valvular insufficiency;
- •Others: persistent active bleeding, vital signs can not be maintained, blood ammonia ≥ 100, total bilirubin > 51umol / L failed to improve after symptomatic treatment; combined active infection, especially biliary system inflammation; female patients are pregnant Or lactation; severe contrast allergy.
研究组 & 干预措施
Left Portal Vein Branch
Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt
干预措施: trans jugular intrahepatic portal systemic shunt (Procedure)
Right Portal Vein Branch
Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt
干预措施: trans jugular intrahepatic portal systemic shunt (Procedure)
结局指标
主要结局
The incidence of HE
时间窗: 2 years
compare difference incidence of HE between shunting left and right portal vein branch
次要结局
未报告次要终点