Dynamic Monitor of Portacaval Pressure Gradient

Study Overview
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Brief Summary
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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. 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.

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

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: Transjugular intrahepatic portosystemic shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with portal hypertensive complications Receiving TIPS due to variceal bleeding or refractory ascites Successful covered TIPS procedure Written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TIPS group<br>Pressure gradient were measured in consecutive cirrhotic patients undergoing TIPS. | Procedure: Transjugular intrahepatic portosystemic shunt<br>* Covered stents will be used, that will be dilated to 8 or 10 mm according to the hemodynamic response. The aim will be to reduce the portacaval pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted. Measurement of portacaval pressure gradient will be done immediate after TIPS, then repeated 1-3 days and at 1 month after the procedure. A TIPS revision will be performed once shunt dysfunction is suspected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of portacaval pressure gradient | The portacaval pressure gradient is the difference between the portal vein and the inferior vena cava pressures during portal angiography | The change of PPG from immediately to 1 month after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal hypertension related complications | The incidence of portal hypertensionrelated bleeding or ascites | 2 years | 
| Other portal hypertension complications | Spontaneous bacterial peritonitis, hepatorenal syndrome. | 2 years | 
| Hepatic encephalopathy | Hepatic encephalopathy | 2 years | 
| Survivial | Time from the procedure to the date of death. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver cirrhosis, Transjugular intrahepatic portosystemic shunt, Pressure gradient, Outcome prediction