Dynamic Monitor of Portacaval Pressure Gradient

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590288
• Other study ID #: PRESSURE GRADIENT MONITOR
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Procedure:
• Transjugular intrahepatic portosystemic shunt
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.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Portal hypertension related complications	The incidence of portal hypertensionrelated bleeding or ascites	3 years
Secondary	Other portal hypertension complications	Spontaneous bacterial peritonitis, hepatorenal syndrome.	3 years
Secondary	Hepatic encephalopathy	Hepatic encephalopathy	3 years
Secondary	Survivial	Time from the procedure to the date of death.	3 years