Status:
RECRUITING
Early TIPS in Patients With Liver Cirrhosis and Ascites
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
Jena University Hospital
Johannes Gutenberg University Mainz
Conditions:
Liver Cirrhosis
Ascites Hepatic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt (TIPS) implantation with standard treatment (diuretic medications, and if necessar...
Detailed Description
Complications in patients with liver cirrhosis are mainly due to the development of clinical significant portal hypertension. These complications include development of varices and ascites. Implantati...
Eligibility Criteria
Inclusion
- Patients eligible for inclusion in this trial must meet all of the following criteria:
- Patients ≥ 18 years and \< 80 years
- Liver cirrhosis as documented by previous liver biopsy or by a combination of typical clinical, biochemical and sonographic features
- Ascites as the first single decompensating event with grade 2 ascites and MELD ≥ 15 OR grade 3 ascites
- INR ≤ 1.5
- Ability to understand the nature of the trial and the trial related procedures and to comply with them
Exclusion
- Patients eligible for this trial must not meet any of the following criteria:
- Treatment refractory or recurrent ascites at the time of study inclusion
- Patients with concomitant variceal bleeding fulfilling the criteria for pre-emptive TIPS implantation (Child-Pugh class C \< 14 points or Child-Pugh class B \>7 with active bleeding at initial endoscopy or hepatic venous pressure gradient \[HVPG\] \> 20 mmHg at the time of bleeding)
- Budd-Chiari syndrome
- Portal vein thrombosis (PVT)
- Spontaneous bacterial peritonitis (SBP)
- Uncontrolled systemic infection (defined as an increase of \> 20% if inflammatory parameters \[C-reactive protein, procalcitonin, leukocytes\] and/or sepsis as a reason for development of ascites
- Cardiac cirrhosis (defined as the development of liver cirrhosis in a patient with cardiac heart failure due to primary cardiac disease)
- Clinical significant cardiac disease (NYHA ≥II)
- Untreated valvular heart disease: middle to high-grade valve stenosis or insufficiency (applies to mitral, tricuspid, aortic and pulmonary valves)
- Diastolic dysfunction grade III, stated by transthoracic echocardiogram (TTE)
- Reduced left ventricular ejection fraction ≤50%
- Pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg)
- Bilirubin \> 3 mg/dl
- Obstructive cholestasis
- Hepatorenal syndrome type AKI (HRS-AKI)
- Acute on chronic liver failure
- Benign liver tumor within the potential puncture tract
- Patient after liver transplantation
- Prior TIPS implantation
- Ongoing and/or recurrent hepatic encephalopathy (grade \>II)
- Active tumor disease including hepatocellular carcinoma defined as need for chemotherapy, radiation therapy, interventional or surgical treatment
- New onset of antiviral treatment for chronic hepatitis B virus (HBV) infection within the last 3 months
- Untreated chronic hepatitis C virus (HCV) infection
- Life expectancy \<1 year
- Pregnant or breastfeeding women
- Patients without the legal capacity who are unable to understand the nature, significance and consequences of the study
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Person who is in a relationship of dependence/employment with the sponsor or the investigator
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2029
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06576934
Start Date
April 1 2025
End Date
February 15 2029
Last Update
April 10 2025
Active Locations (1)
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1
University Medical Center Freiburg
Freiburg im Breisgau, Germany, 79106