NCT Number: NCT05782556
Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial.
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Freiburg im Breisgau, 79106, Germany
Location status: Recruiting
Dominik Bettinger, MD
CONTACT
Dominik Bettinger, MD
PRINCIPAL_INVESTIGATOR
Lukas Sturm, MD
SUB_INVESTIGATOR
Marlene Reincke, MD
SUB_INVESTIGATOR
Michael Schultheiß, MD
SUB_INVESTIGATOR
Patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) can be included in this observational study. Further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 01/01/2023-31/12/2033
Time from study inclusion to death or liver transplantation
Time frame: 01/01/2023-31/12/2033
Time from study inclusion to development of post-TIPS hepatic encephalopathy
Time frame: 01/01/2023-31/12/2033
Time from study inclusion to development of post-TIPS ACLF
Time frame: 01/01/2023-31/12/2033
Time from study inclusion to need for TIPS revision
Time frame: 01/01/2023-31/12/2033
Osteoporosis is assessed by DXA measurement
Time frame: 01/01/2023-31/12/2033
Osteoporosis is assessed by DXA measurement. Bone density will be correlated with prognosis and decompensating events.
Time frame: 01/01/2023-31/12/2033
Sarcopenia is assessed by computed tomography.
Time frame: 01/01/2023-31/12/2033
Sarcopenia is assessed by computed tomography and is correlated with prognosis and the development of decompensating events after TIPS
Time frame: 01/01/2023-31/12/2033
Time from study inclusion to development of post-TIPS infections/sepsis
Time frame: 01/01/2023-31/12/2033
Periinterventional complications (infections, bleeding, biliary injury) are assessed during the intervention. These complications are documented in the report of the intervention and are assessed systematically.
Contact information is provided by the study sponsor or research team.
University Hospital Freiburg
Other
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
Acronym: FRETIR
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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