CirrhosisAnt-TIPSNCT07889726
"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis
A study testing TIPS in people with Cirrhosis, run by University Hospital, Toulouse at 8 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- TIPS
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Jan 2027to 31 Dec 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men,
- 18 years < age ≤ 65 years,
- With cirrhosis and a first PH-related complication defined as a first episode of variceal bleeding and/or a first episode of ascites requiring a paracentesis of > 2 liters (max 2 paracenteses),
- Affiliated to a social insurance system,
- Having signed the written informed consent to participate in the study
- The diagnosis of cirrhosis will be based on Baveno VI conference
Who cannot join
- Patients with variceal bleeding and an indication of TIPS (salvage or pre-emptive TIPS)
- Patients with recurrent ascites (> 2 LVP)
- Common contraindication for TIPS (MELD (Model for End stage Liver Disease) score > 18, Child Pugh score >11 (Appendix 7), Previous overt recurrent/chronic hepatic encephalopathy except during the index episode and High risk of post TIPS cardiac failure.)
- Hepatocellular carcinoma
- Previous liver transplantation
- Previous derivation procedure
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- Untreated chronic viral B or C hepatitis
- Uncontrolled systemic infection/sepsis
- Pregnant or breastfeeding women
- Inability to receive an enlightened information
- Patients participating to another research program
- Patients placed under judicial protection
- No ability for the participant to comply with the requirement of the study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites
Hepatology Department - Besançon University Hospital
Besançon, 25 000
Jean-Paul Cervoni, MD, 03 81 66 80 20 ext. +33, jpcervoni@chu-besancon.fr
Jean-Paul Cervoni, MD
Hepatology Department - Henry Mondor Hospital
Créteil, 94 000
Anna Sessa, MD, anna.sessa@aphp.fr
Anna Sessa, MD
Hepatology Department - La Croix Rousse Hospital
Lyon, 69 004
Teresa Maria Antonini, MD, teresa.antonini@chu-lyon.fr
Terasa Maria Antonini, MD
Hepatology Department - Saint Joseph Hospital
Marseille, 13 008
Floriane Sellier, MD, fsellier@hopital-saint-joseph.fr
Floriane Sellier, MD
Hepatology Department - Hôtel Dieu
Nantes, 44 093
Marion Khaldi, MD, 02 40 08 31 52 ext. +33, marion.khaldi@chu-nantes.fr
Marion Khaldi, MD
Hepatology Department - Pitié Salpétrière Hospital
Paris, 75 013
Marika Rudler, PHD, 01 42 16 14 54 ext. +33, marika.rudler@aphp.fr
Marika Rudler, PHD
Hepatology Department - Pontchaillou Hospital
Rennes, 35 033
Florent Artru, MD, 02 99 28 42 98 ext. +33, florent.artru@univ-rennes.fr
Florent Artru, MD
Hepatology Department - Toulouse University Hospital
Toulouse, 31 059
Christophe Bureau, PHD, 05 61 32 29 60 ext. +33, bureau.c@chu-toulouse.fr
Christophe Bureau, PHD
About this study
Official title: "Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis: a Multicenter, Superiority, Randomized, Controlled Trial, in Parallel Groups
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.
Read the detailed description
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.
- Conditions
- Cirrhosis
- Being tested
- TIPS, Standard of Care (SOC)
- Keywords
- portal hypertension, TIPS, Further decompensation
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPSProcedure or surgery
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).
Standard of Care (SOC)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care arm | Active comparator | The patients included in this group will be treated according to standard medical procedures. Receives: Procedure: Standard of Care (SOC) |
| TIPS procedure | Experimental | The patients included in this group will be treated according to standard medical procedures. Receives: Procedure: TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Bureau, PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889726
- Sponsor's protocol ID
- RC31/25/0534
- Other IDs
- PHRC-24-0214, 2026-A00440-51
- Acronym
- Ant-TIPS
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No