Using TIPS to treat complicated portal hypertension in porto‑sinusoidal vascular disease
Official title: TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Run by Centre Hospitalier Universitaire, Amiens · NCT07163689 · Data updated 2026-11-12
This research tries TIPS (a shunt placed in the liver) for people with porto‑sinusoidal vascular disease who have bleeding, refractory ascites, or portal vein thrombosis from portal hypertension.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 360 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens, Picardie) |
| Status | Recruiting |
| Started | May 16, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT07163689 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a confirmed diagnosis of PSVD (per VALDIG criteria) who need TIPS for variceal bleeding, refractory ascites, or portal vein thrombosis, and matched cirrhotic controls, are ideal candidates.
✕Probably not a fit
Patients without confirmed PSVD or with excluded conditions such as Budd‑Chiari syndrome, significant cardiac failure, Rendu‑Osler disease, Fontan physiology, sarcoidosis, schistosomiasis, congenital liver fibrosis, Abernathy syndrome, or tumor infiltration are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter observational cohort comparing outcomes after TIPS in patients with porto‑sinusoidal vascular disease (PSVD) to a matched group of patients with cirrhosis and portal hypertension complications. Patients are enrolled if they meet VALDIG criteria for PSVD and receive TIPS for variceal bleeding, refractory ascites, or portal vein thrombosis, with matched cirrhotic controls by age, sex, and complication type. The study collects clinical outcomes such as survival, recurrence of bleeding or ascites, and procedure tolerance, aiming to identify predictors of benefit and timing of TIPS. Patients with alternative causes of portal hypertension or major comorbid conditions listed in the exclusion criteria are not included.
Why it matters
Potential benefit: If successful, this work could clarify when TIPS is most helpful in PSVD and improve management and outcomes for patients with complicated portal hypertension.
How similar studies have gone: TIPS is an established therapy in cirrhosis but in PSVD only case reports and small series exist, so large controlled outcome data are currently lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * PSVD group : * Patient with PSVD according VALDIG criteria * TIPS for digestive hemorrhage on portal hypertension * TIPS for refractory ascite * TIPS for portal vein thrombosis * Cirrhosis group with PH : (appaired by age, sexe, type of PH complications) * Confirmed cirrhosis with : * TIPS for digestive hemorrhage on portal hypertension * TIPS for refractory ascite * TIPS for portal vein thrombosis Exclusion Criteria: * no PSVD confirmed diagnosis * Budd Chiari syndrome * Rendu Osler disease; Heart failure * Fontan; Sarcoïdosis * Schistosomiase * Congenitale liver fibrosis * Abernathy syndrome * Tumor infiltration by lymphoma * Bone graft
Where it's running
-
CHU Amiens Picardie
Amiens, Picardie, France Recruiting
Study contacts
- Study coordinator: Eric NGUYEN-KHAC, Pr
- Email: nguyen-khac.eric@chu-amiens.fr
- Phone: 33+3 22 08 88 51
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.