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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05782556
Other study ID # FRETIR01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date June 30, 2034

Study information

Verified date May 2024
Source University Hospital Freiburg
Contact Dominik Bettinger, MD
Phone 49761270-36870
Email dominik.bettinger@uniklinik-freiburg.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date June 30, 2034
Est. primary completion date December 31, 2033
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension Exclusion Criteria: - Withdrawal of written informed consent

Study Design


Intervention

Device:
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

Locations

Country Name City State
Germany University Medical Center Freiburg, Department of Medicine II Freiburg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Transplantation-free survival Time from study inclusion to death or liver transplantation 01/01/2023-31/12/2033
Secondary Time to development of post-TIPS hepatic encephalopathy Time from study inclusion to development of post-TIPS hepatic encephalopathy 01/01/2023-31/12/2033
Secondary Time to development of post-TIPS acute- on chronic liver failure (ACLF) Time from study inclusion to development of post-TIPS ACLF 01/01/2023-31/12/2033
Secondary Time to need for TIPS revision Time from study inclusion to need for TIPS revision 01/01/2023-31/12/2033
Secondary Prevalence of osteoporosis in patients with TIPS implantation Osteoporosis is assessed by DXA measurement 01/01/2023-31/12/2033
Secondary Impact of osteoporosis on prognosis and decompensating events after TIPS Osteoporosis is assessed by DXA measurement. Bone density will be correlated with prognosis and decompensating events. 01/01/2023-31/12/2033
Secondary Prevalence of sarcopenia in patients with TIPS implantation Sarcopenia is assessed by computed tomography. 01/01/2023-31/12/2033
Secondary Impact of sarcopenia on prognosis and decompensating events after TIPS Sarcopenia is assessed by computed tomography and is correlated with prognosis and the development of decompensating events after TIPS 01/01/2023-31/12/2033
Secondary Time to development of post-TIPS infections/sepsis Time from study inclusion to development of post-TIPS infections/sepsis 01/01/2023-31/12/2033
Secondary Periinterventional complications 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. 01/01/2023-31/12/2033
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