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"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis
Sponsor: University Hospital, Toulouse
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 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.
Official title: "Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis: a Multicenter, Superiority, Randomized, Controlled Trial, in Parallel Groups
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2027-01-01
Completion Date
2031-12-31
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
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).
Standard of Care (SOC)
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.
Locations (8)
Hepatology Department - Besançon University Hospital
Besançon, France
Hepatology Department - Henry Mondor Hospital
Créteil, France
Hepatology Department - La Croix Rousse Hospital
Lyon, France
Hepatology Department - Saint Joseph Hospital
Marseille, France
Hepatology Department - Hôtel Dieu
Nantes, France
Hepatology Department - Pitié Salpétrière Hospital
Paris, France
Hepatology Department - Pontchaillou Hospital
Rennes, France
Hepatology Department - Toulouse University Hospital
Toulouse, France