Dynamic Monitor of Portacaval Pressure Gradient

Completed

• Conditions: Liver Cirrhosis
• Interventions: Procedure: Transjugular intrahepatic portosystemic shunt

• Registration Number: NCT03590288
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-18
• Status Verified: 2022-07
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 567

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TIPS group	Transjugular intrahepatic portosystemic shunt	Pressure gradient were measured in consecutive cirrhotic patients undergoing TIPS.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Survivial	3 years	Time from the procedure to the date of death.
Other portal hypertension complications	3 years	Spontaneous bacterial peritonitis, hepatorenal syndrome.
Hepatic encephalopathy	3 years	Hepatic encephalopathy
Portal hypertension related complications	3 years	The incidence of portal hypertensionrelated bleeding or ascites

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China