Observational Study of Transjugular Intrahepatic Portosystemic Shunt TIPS Use in Treating Portal Hypertension

What this Trial Is About

This research focuses on patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are planned to receive a transjugular intrahepatic portosystemic shunt TIPS. The goal is to observe and collect detailed clinical, laboratory, imaging, and outcome data over time to better understand the effects and complications related to TIPS implantation. The study includes both prospectively enrolled patients and those treated retrospectively since 2005. The main intervention involves the implantation of a TIPS via a transjugular approach. During the procedure, a needle is guided into a hepatic vein and then into the portal vein using ultrasound, followed by placement of a stent graft after dilation of the parenchymal tract. Portal and central venous pressures are measured before and after implantation to calculate the pressure gradient. Patients are followed regularly at 3, 6, and 12 months after implantation, with clinical visits and sample collection. Participants will undergo detailed assessments including clinical evaluations, laboratory testing, imaging, and outcome monitoring for complications such as hepatic encephalopathy, liver failure, infections, and the need for TIPS revision. Blood samples and peripheral blood mononuclear cells are collected and stored in a biobank. The primary outcome is transplantation-free survival, with follow-up planned through 2033. This observational study is conducted at the University Medical Center Freiburg and involves regular monitoring and data collection over at least one year post-implantation.

Freiburg TIPS Registry