Early TIPS procedure versus standard care after a first complication of cirrhosis
Compares early TIPS with standard care in adults with cirrhosis after a first complication.
Key facts
- Who runs it
- University Hospital, Toulouse
- Where
- Besançon, Créteil, Lyon, Marseille, Nantes, Paris, Rennes, and Toulouse, FranceSee the 8 sites
- Trial code
- Registry title
- "Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis
- Status
- Not yet recruiting
- People taking part
- 266 people, planned
- Starts
- 1 Jan 2027
- Expected to end
- 31 Dec 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TIPS
- Standard of Care (SOC)
- Record updated
- 22 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cirrhosis who have had a first complication of high pressure in the liver's blood vessels. It compares a TIPS procedure with standard care.
- Age
- Over 18 and up to 65 years.
- Sex
- Women and men can join.
- Disease stage
- Cirrhosis with a first complication of portal hypertension: a first episode of bleeding from varices and/or a first episode of ascites needing a paracentesis of more than 2 liters (at most 2 paracenteses).
- Earlier treatment
- People with a previous liver transplant or a previous derivation procedure cannot join.
Main reasons for not taking part
- Variceal bleeding with an indication for TIPS
- Recurrent ascites (more than 2 large-volume paracenteses)
- Usual reasons TIPS cannot be done, such as MELD score above 18 or Child Pugh score above 11
- Liver cancer (hepatocellular carcinoma)
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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 take part
- 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.)
- Previous liver transplantation
- Previous derivation procedure
- Patients with variceal bleeding and an indication of TIPS (salvage or pre-emptive TIPS)
- Untreated chronic viral B or C hepatitis
- Uncontrolled systemic infection/sepsis
- Patients with recurrent ascites (> 2 LVP)
- Hepatocellular carcinoma
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in France
- Hepatology Department - Besançon University HospitalBesançon, FranceContact: Jean-Paul Cervoni, MDNo longer taking part
- Hepatology Department - Henry Mondor HospitalCréteil, FranceContact: Anna Sessa, MDNo longer taking part
- Hepatology Department - La Croix Rousse HospitalLyon, FranceContact: Teresa Maria Antonini, MDNo longer taking part
- Hepatology Department - Saint Joseph HospitalMarseille, FranceContact: Floriane Sellier, MDNo longer taking part
- Hepatology Department - Hôtel DieuNantes, FranceContact: Marion Khaldi, MDNo longer taking part
- Hepatology Department - Pitié Salpétrière HospitalParis, FranceContact: Marika Rudler, PHDNo longer taking part
- Hepatology Department - Pontchaillou HospitalRennes, FranceContact: Florent Artru, MDNo longer taking part
- Hepatology Department - Toulouse University HospitalToulouse, FranceContact: Christophe Bureau, PHDNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Standard of care armExisting treatment, for comparison
The patients included in this group will be treated according to standard medical procedures.
Treatment: Standard of Care (SOC)
- TIPS procedureTreatment being tested
The patients included in this group will be treated according to standard medical procedures.
Treatment: TIPS
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- "Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis: a Multicenter, Superiority, Randomized, Controlled Trial, in Parallel Groups
- Plain-language title
- Early TIPS procedure versus standard care after a first complication of cirrhosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07889726, who can take part
- Record updated
- 22 October 2026