An interventional study of TIPS and Standard of Care (SOC) in Cirrhosis, sponsored by University Hospital, Toulouse. Not yet recruiting at 8 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
Further decompensation (FD) in cirrhosis represents a prognostic stage associated with an even higher mortality than that associated with the first decompensation. The Baveno VII conference defined FD as a second portal hypertension (PH)-driven decompensating event (ascites, VB, or hepatic encephalopathy) and/or jaundice, or development of spontaneous bacterial peritonitis and/or hepatorenal syndrome-acute kidney injury HRS-AKI. This randomized controlled trial aims to evaluate the effect of TIPS versus standard of care on survival without further decompensation during a 24-month follow up period in patients with cirrhosis after a first PH-related decompensation.
TIPS is now well-validated in patients with: refractory variceal bleeding (VB), failure of VB secondary prophylaxis, recurrent/refractory ascites and in patients with acute VB at high risk of recurrence (pre-emptive TIPS). Further decompensation (FD) in cirrhosis represents a prognostic stage associated with an even higher mortality than that associated with the first decompensation. The Baveno VII conference defined FD as a second portal hypertension (PH)-driven decompensating event (ascites, VB, or hepatic encephalopathy) and/or jaundice, or development of spontaneous bacterial peritonitis and/or hepatorenal syndrome. In the above validated indications of TIPS, the present team has coordinated an IPD meta-analysis including 3924 patients that showed that the cumulative incidence of FD was 0.45 (0.41-0.49) in the TIPS group vs. 0.63 (0.60-0.66) in a in a standard of care (SOC) group (p\<0.0001). The 2-year cumulative survival was higher with TIPS than with SOC (0.71 vs 0.63; p=0.0001). Finally, one small retrospective study including 27 patients showed that "anticipant TIPS", performed after a first VB or a significant episode of ascites, improved 1-year survival in comparison to conventional TIPS (i.e after recurrence): 82% vs 40%.
Patients will be randomly allocated to TIPS or SOC (diuretics and large volume paracentesis LVP when needed in patients with ascites or non-selective betablocker + band ligation in patients with variceal bleeding). Patients will be followed at one month and every three months within two years, thereafter.
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This study's planned enrollment of 266 is above the median of 50 across 2,137 interventional studies indexed under Fibrosis.
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Exclusion Criteria:
The patients included in this group will be treated according to standard medical procedures.
Procedure: Standard of Care (SOC)
The patients included in this group will be treated according to standard medical procedures.
Procedure: TIPS
TIPS will be performed within one month after the index episode (paracentesis \> 2l or variceal bleeding) according to the standardized procedure described recently in the French guidelines (8-10 mm controlled expansion covered stents dilated to 8, or 10 aiming to reduce porto-systemic pressure gradient below 12 mmHg).
In patients included for ascites, patients will be treated by diuretics and LVP and albumin infusion when needed according to the EASL guidelines. In patients included for variceal bleeding, patients will be treated by non-selective betablocker (carvedilol 6.25 mg bid) and endoscopic band ligation (one session every 2-3 weeks until eradication) according to Baveno VII conference and EASL guidelines. Patients with contra-indication to non-selective beta-blocker will be treated by endoscopic band ligation alone and patients with contra-indications to endoscopic band ligation will be treated by carvedilol alone.
Survival without further decompensation
It will be defined as 1 large volume paracentesis \> 2 liters (one month after the randomization in case of ascites) or a new variceal bleeding or a new episode of overt hepatic encephalopathy (grade ≥ 2 of West-Heaven classification) or a new spontaneous bacterial peritonitis (neutrophils \> 250 / mm3 in ascites) or hepatorenal syndrome-acute kidney injury (according to the most recent definition) or jaundice (total bilirubin \> 50 μmol/l). It will be assessed during a 2-year follow-up period.
Time frame: 2 years
Overall survival
It will be assessed by measuring the overall survival, transplantation-free survival and liver-related death (composite criterion) during a 2-year follow up period.
Time frame: 2 years
Incidence of new episode of grade 3 ascites
It will be assessed by the apparition of new episode of grade 3 tense ascites defined as 1 large volume paracentesis \> 2 liters one month after the randomization.
Time frame: 1 month
Number of large volume paracentesis (LVP) episodes per patient
It will be assessed by the apparition of grade 3 tense ascites defined as 1 large volume paracentesis \> 2 liters one month after the randomization.
Time frame: 1 month
Incidence of a new episode of variceal bleeding
It will be assessed by the apparition of new episode of variceal bleeding according to Baveno V definition during a 2-year follow up period.
Time frame: 2 years
Number of digestive bleeding episodes per patient
It will be assessed by the apparition of new episode of variceal bleeding according to Baveno V definition during a 2-year follow up period.
Time frame: 2 years
Incidence of a new episode of overt hepatic encephalopathy (Grade 2 - 4)
It will be assessed by the apparition of new episode of overt hepatic encephalopathy defined as grade \> or = 2 according to the West-Haven classification during a 2-year follow up period. The West-Haven classification is a scale used to assess the severity of hepatic encephalopathy, consisting of 5 grades (0 corresponding to no clinical abnormalities and 4 to coma/unresponsive patient).
Time frame: 2 years
Number of overt hepatic encephalopathy episodes per patient
It will be assessed by the apparition of new episode of overt hepatic encephalopathy defined as grade \> or = 2 according to the West-Haven classification during a 2-year follow up period.
Time frame: 2 years
Incidence of a new episode of severe overt hepatic encephalopathy (Grade 3 - 4)
It will be assessed by the apparition of new episode of severe overt hepatic encephalopathy defined as grade \> or = 3 according to the West-Haven classification during a 2-year follow up period.
Time frame: 2 years
Incidence of a new episode of jaundice
It will be assessed by the apparition of new episode of jaundice defined as total bilirubin \> 50µmol/l during a 2-year follow up period.
Time frame: 2 years
Incidence of new episode of spontaneous bacterial peritonitis (SBP) and hepatorenal syndrome-acute kidney injury (HRS-AKI)
It will be assessed by the apparition of new episode of SBP and HRS-AKI (composite criterion) according to the most recent definition (Nadim et al, J Hepatol 2024) during a 2-year follow up period.
Time frame: 2 years
Number of spontaneous bacterial peritonitis (SBP) and hepatorenal syndrome-acute kidney injury (HRS-AKI) episodes per patient
It will be assessed by the apparition of new episode of SBP and HRS-AKI (composite criterion) according to the most recent definition (Nadim et al, J Hepatol 2024) during a 2-year follow up period.
Time frame: 2 years
Number of acute on chronic liver failure episodes per patient
It will be assessed by the apparition of new episode of acute on chronic liver failure defined according to EASL-CLIF consortium during a 2-year follow up period.
Time frame: 2 years
Number of re-hospitalizations per patient
It will be assessed by the number of re-hospitalizations during a 2-year follow up period.
Time frame: 2 years
Number of days spent in hospitalization
It will be assessed by the number of days spent in hospitalization during a 2-year follow up period.
Time frame: 2 years
Safety throughout the course of the study
It will be assessed by all the adverse events collected during a 2-year follow up period.
Time frame: 2 years
Incidence of a new episode of Acute on Chronic Liver Failure
It will be assessed by the apparitionof new epidose of acute chronic liver failure defined according to EASL-CLIF consortium during a 2 years follow-up period
Time frame: 2 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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