Effect of Diet Management on Incidence of Hepatic Encephalopathy of Patients With Cirrhosis and Variceal Bleeding After Transjugular Intrahepatic Portosystemic Shunt Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Incidence of Hepatic Encephalopathy
研究概览
简要总结
Hepatic encephalopathy is a severe complication of transjugular intrahepatic portosystemic shunt (TIPS) treatment in patients with cirrhosis and variceal bleeding. This study is specially designed to explore whether diet management strategy could decrease incidence of encephalopathy after TIPS treatment.
详细描述
Hepatic encephalopathy (HE) is a severe complication of TIPS treatment in patients with cirrhosis and variceal bleeding. The overall incidence of post-TIPS encephalopathy ranges between 10% and 50%, and even the percentage of the new or worsened HE was evaluated up to 13-36%. No approach or medication was evidenced for prophylaxis of post-TIPS encephalopathy, including lactulose and rifaximin. Diet management has been used as an important part of the prophylaxis and treatment strategy for patients with metabolic diseases like diabetes and nephritis, which has drawn increasing interest of clinicians. Nevertheless, there is still no standard consensus or even recommendation for patients after TIPS procedure for now, which worsened malnutrition and affected survival. Thus, this study is specially designed to explore whether diet management strategy, drawn up from the nutritional management consensus of hepatic encephalopathy (ISHEN consensus), could decrease incidence of encephalopathy after TIPS treatment of the patient with cirrhosis and 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
- Double (Participant, Care Provider)
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
- •patients with decompensated liver cirrhosis regardless of the etiology
- •acute variceal bleeding or with history of variceal bleeding evidenced by endoscopy
- •an age between 18 and 75 years old
排除标准
- •a total bilirubin level more than 3mg/dL (51.3mmol/L)
- •a creatinine level greater than 3 mg/dL(265umol/L)
- •severe dysfunction of heart and respiratory system
- •pregnancy
- •uncontrolled neoplasm
- •active systemic infection
- •history of any kind of encephalopathy, mental disease, alcohol dependence, or any other status that influence brain function
- •diabetes or any other metabolic diseases
研究组 & 干预措施
nutritional management group
diet management strategy for encephalopathy
干预措施: diet management strategy for encephalopathy (Dietary Supplement)
control group
Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department
结局指标
主要结局
Incidence of Hepatic Encephalopathy
时间窗: 1 year
incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment
次要结局
- Liver Transplantation-free Survival Rate(1 year)
- Incidence of Portal Hypertension Related Severe Complications(1 year)
- Change of Nutritional Status(1 year)
- Change of Quality of Life(1 year)
- Incidence of Stent Dysfunction(1 year)
研究者
Li Yang
Clinical Professor
West China Hospital