Actively Recruiting
TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-19
360
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
G
Groupe Hospitalier Pitie-Salpetriere
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of Transjugular Intrahepatic Portosystemic Shunt (TIPS) in patients with Porto-Sinusoidal Vascular Disease (PSVD), a rare condition causing portal hypertension without cirrhosis. This condition can lead to serious complications like digestive bleeding, ascites, or portal vein thrombosis. The study compares outcomes of TIPS in PSVD patients to those in patients with cirrhosis-related portal hypertension to better understand when and how TIPS should be used. This is a retrospective, multicenter observational study involving expert French university centers. It compares a group of PSVD patients who received TIPS with a matched historical group of cirrhosis patients who had TIPS, based on age, sex, and indication for the procedure. No new treatments will be given, and the study observes real-life outcomes. Participants' survival after TIPS placement will be assessed at multiple time points ranging from 3 months to 5 years. Researchers will also monitor recurrence of portal hypertension complications, TIPS dysfunction, and any procedure-related complications during these periods. The study aims to provide detailed data on the safety, tolerance, and timing of TIPS in PSVD compared to cirrhosis.
CONDITIONS
Brief Title
TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with PSVD according to VALDIG criteria
- Undergoing TIPS for digestive hemorrhage due to portal hypertension
- Undergoing TIPS for refractory ascites
- Undergoing TIPS for portal vein thrombosis
- Patients with confirmed cirrhosis and portal hypertension matched by age, sex, and type of PH complications
- Cirrhosis patients undergoing TIPS for digestive hemorrhage, refractory ascites, or portal vein thrombosis
You will not qualify if you...
- No confirmed diagnosis of PSVD
- Presence of Budd Chiari syndrome
- Rendu Osler disease
- Heart failure
- Fontan procedure
- Sarcoidosis
- Schistosomiasis
- Congenital liver fibrosis
- Abernathy syndrome
- Tumor infiltration by lymphoma
- History of bone graft
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (procedure day)
Participants undergo TIPS (transjugular intrahepatic portosystemic shunt) placement as part of their clinical care for complications related to portal hypertension.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed over several years to monitor survival and recurrence of portal hypertension complications after TIPS placement.
Periodic visits depending on clinical follow-up
Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
E
Eric NGUYEN-KHAC, Pr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here