Dynamic Monitor of Portacaval Pressure Gradient and Its Prognostic Value in Predicting Outcomes in Patients Undergoing TIPS
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
- 否
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
Guohong Han
Head of Department of Digestive Interventional Radiology
Air Force Military Medical University, China
