Registry for patients undergoing TIPS implantation for portal hypertension
Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
University Hospital Freiburg · NCT05782556
This study is collecting information from patients with serious portal hypertension who are getting a TIPS procedure to see how well it works and what complications might happen afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital Freiburg (other) |
| Locations | 1 site (Freiburg im Breisgau) |
| Trial ID | NCT05782556 on ClinicalTrials.gov |
What this trial studies
This observational registry collects data from patients with clinically significant portal hypertension who are scheduled for transjugular intrahepatic portosystemic shunt (TIPS) implantation at the University Medical Center Freiburg. Patients will be assessed for clinical, laboratory, and outcome parameters before and up to 12 months after the procedure. Additionally, serum/plasma samples and peripheral blood mononuclear cells will be collected for biobanking. The study aims to evaluate the outcomes related to TIPS implantation, including complications and the need for further interventions.
Who should consider this trial
Good fit: Ideal candidates are patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are scheduled for TIPS implantation.
Not a fit: Patients who are not allocated to TIPS implantation or who withdraw consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of outcomes and complications associated with TIPS implantation, potentially leading to better management of portal hypertension.
How similar studies have performed: While observational studies on TIPS have been conducted, this specific registry approach focusing on comprehensive data collection and biobanking is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Freiburg im Breisgau
- University Medical Center Freiburg, Department of Medicine II — Freiburg im Breisgau, Germany (RECRUITING)
Study contacts
- Principal investigator: Dominik Bettinger, MD — University Hospital Freiburg
- Study coordinator: Dominik Bettinger, MD
- Email: dominik.bettinger@uniklinik-freiburg.de
- Phone: 49761270-36870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cirrhosis, Portal Hypertension, Non-Cirrhotic Portal Hypertension, Budd Chiari Syndrome, Portal Vein Thrombosis, Portal Systemic Shunt, Liver cirhosis, Transjugular intrahepatic portosystemic shunt