Liver Cirrhosis
Conditions
Keywords
Liver cirrhosis, Transjugular intrahepatic portosystemic shunt, Pressure gradient, Outcome prediction
Brief summary
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.
Interventions
Covered stents will be used, that will be dilated to 8 mm. 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.
Sponsors
Air Force Military Medical University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of portacaval pressure gradient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Portal hypertension related complications | 3 years | The incidence of portal hypertensionrelated bleeding or ascites |
| Other portal hypertension complications | 3 years | Spontaneous bacterial peritonitis, hepatorenal syndrome. |
| Hepatic encephalopathy | 3 years | Hepatic encephalopathy |
| Survivial | 3 years | Time from the procedure to the date of death. |
Countries
China
Outcome results
None listed