NCT05782556

Freiburg TIPS Registry

Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis
• Portal Hypertension
• Non-Cirrhotic Portal Hypertension
• Budd Chiari Syndrome
• Portal Vein Thrombosis
• Portal Systemic Shunt

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2033-12-31
• Completion: 2034-06-30
• First posted: 2023-03-23
• Last updated: 2024-05-08

Locations

1 site across 1 country: Germany