Dynamic Monitor of Portacaval Pressure Gradient

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Procedure: Transjugular intrahepatic portosystemic shunt

Study type: Observational

Funder types: Other

Identifiers

NCT03590288

PRESSURE GRADIENT MONITOR

Details and patient eligibility

About

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.

Enrollment: 567 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

567 participants in 1 patient group

TIPS group

Description:

Pressure gradient were measured in consecutive cirrhotic patients undergoing TIPS.

Treatment:

Procedure: Transjugular intrahepatic portosystemic shunt