Freiburg TIPS Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital Freiburg

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)

    Device

    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

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS)1 intervention

Trial outcomes

Primary outcomes

1

Transplantation-free survival

Time from study inclusion to death or liver transplantation

Time frame
01/01/2023-31/12/2033

Secondary outcomes

1

Time to development of post-TIPS hepatic encephalopathy

Time from study inclusion to development of post-TIPS hepatic encephalopathy

Time frame
01/01/2023-31/12/2033
2

Time to development of post-TIPS acute- on chronic liver failure (ACLF)

Time from study inclusion to development of post-TIPS ACLF

Time frame
01/01/2023-31/12/2033
3

Time to need for TIPS revision

Time from study inclusion to need for TIPS revision

Time frame
01/01/2023-31/12/2033
4

Prevalence of osteoporosis in patients with TIPS implantation

Osteoporosis is assessed by DXA measurement

Time frame
01/01/2023-31/12/2033

Other outcomes

Sponsors and contacts

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