Dynamic Monitor of Portacaval Pressure Gradient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

567 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TIPS group

Pressure gradient were measured in consecutive cirrhotic patients undergoing TIPS.

Transjugular intrahepatic portosystemic shunt

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No