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Dynamic Monitor of HVPG and Its Prognostic Value in Predicting Outcomes in Patients Undergoing TIPS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590288
Recruitment Status : Unknown
Verified August 2019 by Guohong Han, Air Force Military Medical University, China.
Recruitment status was:  Recruiting
First Posted : July 18, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Air Force Military Medical University, China

Study Description
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Brief Summary:
Pressure gradient plays an important role in prediction the outcomes of cirrhotic patients undergoing TIPS. An HVPG over 20 mmHg indicates a high risk of failure to control bleeding or preventing rebleeding, while patients with HVPG <12 mmHg are free from the risk of variceal bleeding. This study aims to dynamically monitor the change of HVPG after TIPS procedure, and investigate its prognostic value in predicting patient outcome

Condition or disease Intervention/treatment
Liver Cirrhosis Procedure: Transjugular intrahepatic portosystemic shunt

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Monitor of HVPG and Its Prognostic Value in Predicting Outcomes in Patients Undergoing TIPS
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

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Groups and Cohorts
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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 or 10 mm according to the hemodynamic response. The aim will be to reduce the portal 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 pressure gradient will be repeated within 3 days after the procedure and then at 1 month and 6 months after the procedure.

A TIPS revision will be performed once shunt dysfunction is suspected.


Outcome Measures
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Primary Outcome Measures :
  1. Change of hepatic venous pressure gradient / portosystemic pressure gradient [ Time Frame: The change of pressure gradient from immediately to 1 month after the procedure ]
    The pressure gradient between portal vein and hepatic vein measured during portal angiography


Secondary Outcome Measures :
  1. Variceal bleeding [ Time Frame: 2 years ]
    The incidence of clinically significant gastrointestinal variceal bleeding

  2. Ascites [ Time Frame: 2 years ]
    The incidence of ascites detected by ultrasound

  3. Shunt dysfunction [ Time Frame: 2 years ]
    The incidence of stenosis or occlusion of the TIPS stent

  4. Other portal hypertension complications [ Time Frame: 2 years ]
    hepatorenal syndrome, jaudice, etc.

  5. Hepatic encephalopathy [ Time Frame: 2 years ]
    Hepatic encephalopathy

  6. Liver transplant-free survivial [ Time Frame: 2 years ]
    Time from the procedure to the date of lost-to-follow-up or death or liver transplant


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive cohort meeting the abovementioned criteria
Criteria

Inclusion Criteria:

  • Liver cirrhosis diagnosed by clinical examination, imaging or biopsy.
  • 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
  • Allergic to contrast agent
  • History of spontaneous overt HE or recurrent HE
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590288


Contacts
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Contact: Guohong Han, MD, PhD 86-29-84771537 hangh@fmmu.edu.cn

Locations
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China, Shaanxi
Xijing Hospital of Digestive Diseases, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Guohong Han, MD, PhD    86-29-84771537    hangh@fmmu.edu.cn   
Sponsors and Collaborators
Air Force Military Medical University, China
More Information
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Responsible Party: Guohong Han, Head of Department of Digestive Interventional Radiology, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT03590288    
Other Study ID Numbers: PRESSURE GRADIENT MONITOR
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guohong Han, Air Force Military Medical University, China:
Liver cirrhosis
Transjugular intrahepatic portosystemic shunt
Pressure gradient
Outcome prediction
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases