NCT07889726Not yet recruiting
"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis
"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis: a Multicenter, Superiority, Randomized, Controlled Trial, in Parallel Groups
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 266 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- High blood pressure
- NCT number
- NCT07889726
What you commit to
- Study type: Interventional
- Planned participants: 266
- From 1 Jan 2027 to the primary completion date, 31 Dec 2031
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hepatology Department - Besançon University Hospital Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Hepatology Department - Henry Mondor Hospital Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| Hepatology Department - La Croix Rousse Hospital Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hepatology Department - Saint Joseph Hospital Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hepatology Department - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hepatology Department - Pitié Salpétrière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hepatology Department - Pontchaillou Hospital Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Hepatology Department - Toulouse University Hospital Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.