Freiburg TIPS Registry

Recruiting

• Conditions: Portal Hypertension; Budd Chiari Syndrome; Portal Systemic Shunt; Liver Cirrhosis; Portal Vein Thrombosis; Non-Cirrhotic Portal Hypertension
• Interventions: Device: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)

• Registration Number: NCT05782556
• Lead Sponsor: University Hospital Freiburg

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-03-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2033-12-31
• Study Completion: 2034-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Read More

Exclusion Criteria

• Withdrawal of written informed consent

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS)	Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)	Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) due to cirrhotic and non-cirrhotic portal hypertension

Primary Outcome Measures

Name	Time	Method
Transplantation-free survival	01/01/2023-31/12/2033	Time from study inclusion to death or liver transplantation

Secondary Outcome Measures

Name	Time	Method
Impact of osteoporosis on prognosis and decompensating events after TIPS	01/01/2023-31/12/2033	Osteoporosis is assessed by DXA measurement. Bone density will be correlated with prognosis and decompensating events.
Impact of sarcopenia on prognosis and decompensating events after TIPS	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
Periinterventional complications	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.
Time to development of post-TIPS hepatic encephalopathy	01/01/2023-31/12/2033	Time from study inclusion to development of post-TIPS hepatic encephalopathy
Time to development of post-TIPS acute- on chronic liver failure (ACLF)	01/01/2023-31/12/2033	Time from study inclusion to development of post-TIPS ACLF
Prevalence of osteoporosis in patients with TIPS implantation	01/01/2023-31/12/2033	Osteoporosis is assessed by DXA measurement
Prevalence of sarcopenia in patients with TIPS implantation	01/01/2023-31/12/2033	Sarcopenia is assessed by computed tomography.
Time to development of post-TIPS infections/sepsis	01/01/2023-31/12/2033	Time from study inclusion to development of post-TIPS infections/sepsis
Time to need for TIPS revision	01/01/2023-31/12/2033	Time from study inclusion to need for TIPS revision

Trial Locations

Locations (1)

University Medical Center Freiburg, Department of Medicine II; 🇩🇪 Freiburg, Germany