Freiburg TIPS Registry

Liver Cirrhosis Clinical Trial

— FRETIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782556
• Other study ID #: FRETIR01
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: June 30, 2034

Study information

• Verified date: May 2024
• Source: University Hospital Freiburg
• Contact: Dominik Bettinger, MD
• Phone: 49761270-36870
• Email: dominik.bettinger[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 30, 2034
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Withdrawal of written informed consent

Related Conditions & MeSH terms

• Budd-Chiari Syndrome
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Non-Cirrhotic Portal Hypertension
• Portal Hypertension
• Portal Vein Thrombosis
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Freiburg, Department of Medicine II	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplantation-free survival	Time from study inclusion to death or liver transplantation	01/01/2023-31/12/2033
Secondary	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
Secondary	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
Secondary	Time to need for TIPS revision	Time from study inclusion to need for TIPS revision	01/01/2023-31/12/2033
Secondary	Prevalence of osteoporosis in patients with TIPS implantation	Osteoporosis is assessed by DXA measurement	01/01/2023-31/12/2033
Secondary	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
Secondary	Prevalence of sarcopenia in patients with TIPS implantation	Sarcopenia is assessed by computed tomography.	01/01/2023-31/12/2033
Secondary	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
Secondary	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
Secondary	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

External Links

•   Homepage Interventional Hepatology University Medical Center Freiburg