Clinical trial NCT05782556: Freiburg TIPS Registry
Official title: Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Portal Hypertension
Non-Cirrhotic Portal Hypertension
Budd Chiari Syndrome
Portal Vein Thrombosis
Portal Systemic Shunt
Keywords: Liver cirhosis
Transjugular intrahepatic portosystemic shunt
Non-Cirrhotic Portal Hypertension
Prognosis
Outcome
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension

Exclusion Criteria:

* Withdrawal of written informed consent

Primary outcomes:
measure: Transplantation-free survival
timeFrame: 01/01/2023-31/12/2033
Secondary outcomes:
measure: Time to development of post-TIPS hepatic encephalopathy
timeFrame: 01/01/2023-31/12/2033
measure: Time to development of post-TIPS acute- on chronic liver failure (ACLF)
timeFrame: 01/01/2023-31/12/2033
measure: Time to need for TIPS revision
timeFrame: 01/01/2023-31/12/2033
measure: Prevalence of osteoporosis in patients with TIPS implantation
timeFrame: 01/01/2023-31/12/2033
measure: Impact of osteoporosis on prognosis and decompensating events after TIPS
timeFrame: 01/01/2023-31/12/2033
measure: Prevalence of sarcopenia in patients with TIPS implantation
timeFrame: 01/01/2023-31/12/2033
measure: Impact of sarcopenia on prognosis and decompensating events after TIPS
timeFrame: 01/01/2023-31/12/2033
measure: Time to development of post-TIPS infections/sepsis
timeFrame: 01/01/2023-31/12/2033
measure: Periinterventional complications
timeFrame: 01/01/2023-31/12/2033
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg, Department of Medicine II
Study officials:
affiliation: University Hospital Freiburg
name: Dominik Bettinger, MD
role: PRINCIPAL_INVESTIGATOR
References: