Actively Recruiting

Age: 18Years - 100Years
All Genders
ID05782556

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

Led by University Hospital Freiburg · Updated on 2026-05-01

2000

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Brief Title

Freiburg TIPS Registry

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension
Not Eligible

You will not qualify if you...

  • Withdrawal of written informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 day

Participants undergo implantation of a transjugular intrahepatic portosystemic shunt (TIPS) using a transjugular approach with ultrasound guidance.

1 visit (in-person)

Long-term Monitoring

Duration - At least 12 months

Participants are followed up for at least 12 months to assess clinical outcomes including hepatic encephalopathy, acute-on-chronic liver failure, infections, TIPS revision, transplantation, and survival.

Visits at 3, 6, and 12 months after TIPS implantation

Trial Site Locations

Total: 1 location

1

University Medical Center Freiburg, Department of Medicine II

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

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Research Team

D

Dominik Bettinger, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt.

Lukas A Heger, Johannes Chang, Charlotte Rohrer...

https://pubmed.ncbi.nlm.nih.gov/41204773