Freiburg TIPS Registry (FRETIR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Portal Hypertension; Portal Vein Thrombosis; Non-Cirrhotic Portal Hypertension; Budd Chiari Syndrome; Portal Systemic Shunt
• Intervention / Treatment: Device: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS)

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Dominik Bettinger, MD; Phone Number: 49761270-36870; Email: dominik.bettinger@uniklinik-freiburg.de

Study Locations

• Germany
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • University Medical Center Freiburg, Department of Medicine II
    • Contact: Dominik Bettinger, MD; Phone Number: 49761270-36870; Email: dominik.bettinger@uniklinik-freiburg.de
    • Principal Investigator: Dominik Bettinger, MD
    • Sub-Investigator: Michael Schultheiß, MD
    • Sub-Investigator: Lukas Sturm, MD
    • Sub-Investigator: Marlene Reincke, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Withdrawal of written informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transplantation-free survival	Time from study inclusion to death or liver transplantation	01/01/2023-31/12/2033

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to development of post-TIPS hepatic encephalopathy	Time from study inclusion 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)	Time from study inclusion to development of post-TIPS ACLF	01/01/2023-31/12/2033
Time to need for TIPS revision	Time from study inclusion to need for TIPS revision	01/01/2023-31/12/2033
Prevalence of osteoporosis in patients with TIPS implantation	Osteoporosis is assessed by DXA measurement	01/01/2023-31/12/2033
Impact of osteoporosis on prognosis and decompensating events after TIPS	Osteoporosis is assessed by DXA measurement. Bone density will be correlated with prognosis and decompensating events.	01/01/2023-31/12/2033
Prevalence of sarcopenia in patients with TIPS implantation	Sarcopenia is assessed by computed tomography.	01/01/2023-31/12/2033
Impact of sarcopenia on prognosis and decompensating events after TIPS	Sarcopenia is assessed by computed tomography and is correlated with prognosis and the development of decompensating events after TIPS	01/01/2023-31/12/2033
Time to development of post-TIPS infections/sepsis	Time from study inclusion to development of post-TIPS infections/sepsis	01/01/2023-31/12/2033
Periinterventional complications	Periinterventional complications (infections, bleeding, biliary injury) are assessed during the intervention. These complications are documented in the report of the intervention and are assessed systematically.	01/01/2023-31/12/2033

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Investigators: Principal Investigator: Dominik Bettinger, MD, University Hospital Freiburg

Publications and helpful links

General Publications

• 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.

Helpful Links

• Homepage Interventional Hepatology University Medical Center Freiburg

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): June 30, 2034

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prognosis; Outcome; Transjugular intrahepatic portosystemic shunt; Non-Cirrhotic Portal Hypertension; Liver cirhosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Digestive System Diseases; Liver Diseases; Embolism and Thrombosis; Fibrosis; Venous Thrombosis; Thrombosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis; Hypertension, Portal; Budd-Chiari Syndrome
• Other Study ID Numbers: FRETIR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No