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临床试验/NCT05128305
NCT05128305Unknown3 期

Shandong Provincial Integrated Traditional Chinese and Clinical Medicine(Chronic Hepatitis B and Its Complication) Prevention and Treatment Project

Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
276
试验地点
1
主要终点
The incidence of hepatic encephalopathy

研究概览

简要总结

Hepatic encephalopathy is the most common complication after TIPS, and hepatic encephalopathy occurs in almost all portosystemic shunts. For patients with severe upper gastrointestinal bleeding or refractory ascites in the decompensated chronic hepatitis B, transjugular intrahepatic portosystemic shunt (TIPS) is a very effective treatment. However, due to the severe complications such as hepatic encephalopathy after TIPS, the clinical application of TIPS is limited. Literature studies have shown that the incidence of encephalopathy after TIPS is about 35%. TIPS reduces the portal vena blood flow into the liver by establishing a new channel. But at the same time, the toxic substances from the gastrointestinal tract and other organs do not enter the liver to detoxify, and are more likely to enter the brain, leading to hepatic encephalopathy.

Moreover, studies have found that the liver and the intestine originate from the same germ layer and are closely related to each other in anatomy and function. There are a large number of microorganisms living in the intestinal tract. Normally, the intestinal tract, as the first defense of the human body, can effectively prevent bacteria and their products from entering the bloodstream. In cirrhosis and portal hypertension, blood return disorder causes intestinal damage. A series of microbes and product endotoxins such as gram-negative bacteria will enter the blood through the injury, and the toxins in the peripheral blood will enter the brain and cause hepatic encephalopathy happened.

The research team's early treatment plan with integrated traditional Chinese and Western medicine proved that it greatly reduced the incidence of hepatic encephalopathy after TIPS. And improve the clinical symptoms and signs of patients with liver cirrhosis, and improve the quality of life and survival of patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • TIPS treatment criteria in line with the 2017 edition of the "Expert Consensus on Transjugular Intrahepatic Portosystemic Shunt" were selected to include patients with hepatitis B cirrhosis and Child-pugh grade A and B after TIPS surgery.
  • Patients with liver cirrhosis, portal hypertension, bleeding from esophagus and gastric varices; refractory pleural and ascites due to liver cirrhosis; incomplete portal vein/localized thrombosis in liver cirrhosis or primary and secondary prevention of cirrhosis, portal hypertension, esophagus and gastric varices bleeding.

排除标准

  • Severe blood coagulation disorder (PTA≤20%) or platelets lower than 30×109/L;
  • Child-pugh classification of liver function C;
  • Those with respiratory and circulatory dysfunction;
  • Those whose systemic or focal infections have not been effectively controlled;
  • Patients with moderate to severe malnutrition;
  • Extensive primary or metastatic liver malignant tumors;
  • Those who are highly allergic to the products and drugs used in the treatment process.

研究组 & 干预措施

group 1

Experimental

traditional chinese medicine 1 and traditional chinese medicine 2 simulant

干预措施: traditional Chinese medicine1 and traditional Chinese medicine 2 (Drug)

group 2

Experimental

traditional chinese medicine 1 simulant and traditional chinese medicine 2

干预措施: traditional Chinese medicine1 and traditional Chinese medicine 2 (Drug)

group 3

Experimental

traditional chinese medicine 1 and traditional chinese medicine 2

干预措施: traditional Chinese medicine1 and traditional Chinese medicine 2 (Drug)

group 4

Placebo Comparator

traditional chinese medicine 1 simulant and traditional chinese medicine 2 simulant

干预措施: traditional Chinese medicine1 and traditional Chinese medicine 2 (Drug)

结局指标

主要结局

The incidence of hepatic encephalopathy

时间窗: 12 weeks of treatment

The incidence of hepatic encephalopathy after 12 weeks of treatment.

次要结局

未报告次要终点

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lili Cao

Professor

Qianfoshan Hospital

研究点 (1)

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