About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension
Disqualifiers
Withdrawal of written informed consent
Trial population
Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension will be included in this study.In summary, patients with the folowing conditions can be included: * liver cirrhosis and indication for TIPS implantation (pre-emptive TIPS or rescue TIPS in case of varical bleeding, secondary prophylaxis of varical bleeding, recurrent or refractory ascites, TIPS before surgery) * non-cirrhotic portal vein thrombosis * Budd-Chiari syndrome * porto-sinusoidal vascular disease
Trial design
Cohort
Prospective
Treatments tested in this trial
Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
DeviceFor 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
Treatment groups
Trial outcomes
Primary outcomes
Transplantation-free survival
Time from study inclusion to death or liver transplantation
Secondary outcomes
Time to development of post-TIPS hepatic encephalopathy
Time from study inclusion to development of post-TIPS hepatic encephalopathy
Time to development of post-TIPS acute- on chronic liver failure (ACLF)
Time from study inclusion to development of post-TIPS ACLF
Time to need for TIPS revision
Time from study inclusion to need for TIPS revision
Prevalence of osteoporosis in patients with TIPS implantation
Osteoporosis is assessed by DXA measurement
Sponsors and contacts
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