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Completed

NCT Number: NCT03590288

Dynamic Monitor of Portacaval Pressure Gradient

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transjugular intrahepatic portosystemic shunt

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.

Primary outcomes

  1. Change of portacaval pressure gradient

    Time frame: 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 outcomes

  1. Portal hypertension related complications

    Time frame: 3 years

    The incidence of portal hypertensionrelated bleeding or ascites

  2. Other portal hypertension complications

    Time frame: 3 years

    Spontaneous bacterial peritonitis, hepatorenal syndrome.

  3. Hepatic encephalopathy

    Time frame: 3 years

    Hepatic encephalopathy

  4. Survivial

    Time frame: 3 years

    Time from the procedure to the date of death.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2018
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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