Freiburg TIPS Registry

NCT05782556 | Recruiting

• 1 other identifier: FRETIR01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Liver cirhosis; Transjugular intrahepatic portosystemic shunt; Non-Cirrhotic Portal Hypertension; Prognosis; Outcome

Outcome Measures

Primary Outcomes (1)

• Transplantation-free survival

  Time from study inclusion to death or liver transplantation

  01/01/2023-31/12/2033

Secondary Outcomes (9)

• Time to development of post-TIPS hepatic encephalopathy

  01/01/2023-31/12/2033

• Time to development of post-TIPS acute- on chronic liver failure (ACLF)

  01/01/2023-31/12/2033

• Time to need for TIPS revision

  01/01/2023-31/12/2033

• Prevalence of osteoporosis in patients with TIPS implantation

  01/01/2023-31/12/2033

• Impact of osteoporosis on prognosis and decompensating events after TIPS

  01/01/2023-31/12/2033

Study Arms (1)

Patients allocated to 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

Device: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)

Interventions

Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) DEVICE

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

Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension will be included in this study.In summary, patients with the folowing conditions can be included: * liver cirrhosis and indication for TIPS implantation (pre-emptive TIPS or rescue TIPS in case of varical bleeding, secondary prophylaxis of varical bleeding, recurrent or refractory ascites, TIPS before surgery) * non-cirrhotic portal vein thrombosis * Budd-Chiari syndrome * porto-sinusoidal vascular disease

You may qualify if:

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

You may not qualify if:

• Withdrawal of written informed consent

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Medical Center Freiburg, Department of Medicine II

Freiburg im Breisgau, 79106, Germany

RECRUITING

Related Publications (1)

• Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422.

  PMID: 41204773 DERIVED

Related Links

• Homepage Interventional Hepatology University Medical Center Freiburg

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, peripheral blood mononuclear cell (PBMC)

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Budd-Chiari Syndrome

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dominik Bettinger, MD

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Bettinger, MD

CONTACT

49761270-36870; dominik.bettinger@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): June 30, 2034
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)