Dynamic Monitor of Portacaval Pressure Gradient

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: Transjugular intrahepatic portosystemic shunt

• Study Type: Observational
• Enrollment (Actual): 567

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive cohort meeting the abovementioned criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

TIPS group; Pressure gradient were measured in consecutive cirrhotic patients undergoing TIPS.

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.

What is the study measuring?

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	3 years
Other portal hypertension complications	Spontaneous bacterial peritonitis, hepatorenal syndrome.	3 years
Hepatic encephalopathy	Hepatic encephalopathy	3 years
Survivial	Time from the procedure to the date of death.	3 years

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Liver cirrhosis; Outcome prediction; Transjugular intrahepatic portosystemic shunt; Pressure gradient
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: PRESSURE GRADIENT MONITOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No