跳至主要内容
临床试验/NCT03590288
NCT03590288已完成不适用

Dynamic Monitor of Portacaval Pressure Gradient and Its Prognostic Value in Predicting Outcomes in Patients Undergoing TIPS

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
567
试验地点
1
主要终点
Change of portacaval pressure gradient

研究概览

简要总结

Portacaval pressure gradient (PPG) plays an important role in prediction the outcomes of cirrhotic patients undergoing TIPS. An PPG over 20 mmHg indicates a high risk of failure to control bleeding or preventing rebleeding, while patients with PPG <12 mmHg are free from the risk of variceal bleeding. Transjugular intrahepatic portosystemic shunt (TIPS) markedly reduces PPG and is a very effective treatment for portal hypertension. A recent study showed that timing affects measurement of portacaval pressure gradient (PPG) after TIPS placement in patients with portal hypertension. The immediate PPG after TIPS placement cannot predict the long-term prognosis, while PPG measured with the patient on stable clinical conditions correlates with long term PPG and clinical outcomes. However, this finding remain to be validated. Previous studies have demonstrated that the achievement of a hepatic vein pressure gradient <12 mmHg eliminated the risk of recurrent variceal hemorrhage. Therefore, a post- TIPS PPG <12 mmHg was initially proposed as a hemodynamic target of TIPS, independent of the indication. It is important to note that most studies on hemodynamic targets were done before the introduction of covered stents and have not been adequately updated since then.Therefore, whether a post-TIPS PPG target <12 mmHg is the best cutoff for patients receiving a covered stent for the treatment of portal hypertension complications needs confirmation in well-designed studies.This study aims to dynamically monitor the change of PPG after TIPS procedure in patients with portal hypertension, and investigate its prognostic value in predicting patient outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Patients with portal hypertensive complications
  • Receiving TIPS due to variceal bleeding or refractory ascites
  • Successful covered TIPS procedure
  • Written informed consent

排除标准

  • Lactating or pregnant
  • Malignancies
  • Uncontrolled infection (> grade 2)
  • Severe cardiac, pulmonary or renal dysfunction
  • Previously treated with TIPS
  • Previous liver transplantation
  • History of spontaneous overt HE or recurrent HE

结局指标

主要结局

Change of portacaval pressure gradient

时间窗: The change of PPG from immediately to 1 month after the procedure

The portacaval pressure gradient is the difference between the portal vein and the inferior vena cava pressures during portal angiography

次要结局

  • Other portal hypertension complications(3 years)
  • Hepatic encephalopathy(3 years)
  • Portal hypertension related complications(3 years)
  • Survivial(3 years)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guohong Han

Head of Department of Digestive Interventional Radiology

Air Force Military Medical University, China

研究点 (1)

Loading locations...

相似试验