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New treatment option for Liver Cirrhosis
Official title Early TIPS in Patients With Liver Cirrhosis and Ascites
ClinicalTrials.gov ID: NCT06576934
What this study is testing
- What it's testing
- 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 necessary, paracenteses) in patients with liver cirrhosis and development of ascites as the first decompensating event. By creating a shunt between the liver vein and the portal vein, blood is diverted from the portal vein directly into the hepatic vein, which results in a reduction of pressure in the portal vein so that development of ascites is reduced.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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 \ 7 with active bleeding at...
- Budd-Chiari syndrome
- Portal vein thrombosis (PVT)
- Spontaneous bacterial peritonitis (SBP)
See the full eligibility criteria
- 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
- 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 \ 7 with active bleeding at initial endoscopy or hepatic venous pressure gradient [HVPG] \> 20...
- 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, treatment 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Freiburg im Breisgau, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Freiburg im Breisgau, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.