Study Results
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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RECRUITING
2000 participants
OBSERVATIONAL
2023-01-01
2034-06-30
Brief Summary
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Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.
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Detailed Description
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Patients who are allocated to TIPS implantation will be recruited the day before TIPS implantation. Detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. Further, interventional data of TIPS implantation will be included in the database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins and from the liver and portal vein that will be taken during TIPS implantation.
All patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after TIPS implantation.
Outcome parameters including development of post-TIPS hepatic encephalopathy, acute- on chronic liver failure (ACLF), infections, recurrence of clinically significant portal hypertension, need for TIPS revision and death and liver transplantation will be assessed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) due to cirrhotic and non-cirrhotic portal hypertension
Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
For TIPS implantation, a transjugular approach is used in all patients and a puncture needle was advanced into a hepatic vein. Puncture of the portal vein is performed using ultrasound guidance followed by portography after successful puncture of the portal vein. Further, the parenchymal tract isdilated and the stent graft is placed. Before and after TIPS implantation, portal venous and central venous pressures are measured to calculate the porto-systemic pressure gradient
Interventions
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Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
For TIPS implantation, a transjugular approach is used in all patients and a puncture needle was advanced into a hepatic vein. Puncture of the portal vein is performed using ultrasound guidance followed by portography after successful puncture of the portal vein. Further, the parenchymal tract isdilated and the stent graft is placed. Before and after TIPS implantation, portal venous and central venous pressures are measured to calculate the porto-systemic pressure gradient
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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University Hospital Freiburg
OTHER
Responsible Party
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PD Dr. Dominik Bettinger
MD
Principal Investigators
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Dominik Bettinger, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Freiburg
Locations
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University Medical Center Freiburg, Department of Medicine II
Freiburg im Breisgau, , Germany
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Homepage Interventional Hepatology University Medical Center Freiburg
Other Identifiers
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FRETIR01
Identifier Type: -
Identifier Source: org_study_id
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