Early TIPS in Patients With Liver Cirrhosis and Ascites
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital Freiburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Transjugular intrahepatic portosystemic shunt (TIPS)
Procedure/SurgeryTIPS implantation is performed by creating a shunt between the liver vein and the portal vein to enable portal pressure reduction.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Transjugular intrahepatic portosystemic shunt (TIPS)Experimental treatment 1 intervention
Group B: Standard medical treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Transplantation-free survival (TFS)
The primary objective of this study is to assess a survival benefit in patients with early allocation to TIPS implantation in comparison to patients with standard medical treatment (SMT).
Time frame
Through study completion, an average of 12 monthsSecondary outcomes
1
Time to ascites with need for paracenteses
Assessment of the duration until the next paracentesis after randomisation occurs to compare the efficacy of TIPS implantation compared to standard medical treatment.
Time frame
Through study completion, an average of 12 months2
Assessment of quality of life
Quality of life assessed with the SF-36 and CLDQ (chronic liver disease questionnaire) before TIPS implantation/study inclusion, 6 and 12 months after randomisation.
Time frame
Through study completion, an average of 1 year: at study inclusion, at 6 and 12 months after randomisation3
Rate of TIPS implantation in the standard medical treatment group
Need for TIPS implantation (recurrent ascites or variceal bleeding) in the standard medical treatment group.
Time frame
Through study completion, an average of 12 months4
Rate of TIPS dysfunction
Development of TIPS dysfunction in the TIPS group
Time frame
Through study completion, an average of 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Freiburg
Lead sponsor
Jena University Hospital
Collaborator
Johannes Gutenberg University Mainz
Collaborator
University Hospital Muenster
Collaborator
University Hospital, Bonn
Collaborator
University Hospital Munich
Collaborator
Hannover Medical School
Collaborator
University of Leipzig
Collaborator
University Hospital, Aachen
Collaborator
University Hospital Lübeck
Collaborator
Heinrich-Heine University, Duesseldorf
Collaborator
Source ClinicalTrials.gov