Using TIPS to treat complicated portal hypertension in porto‑sinusoidal vascular disease
TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Centre Hospitalier Universitaire, Amiens · NCT07163689
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 |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens (other) |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT07163689 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens, Picardie
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: TIPS, Portal Hypertension, Porto-Sinusoidal Vascular Disease, Refractory Ascite, Esophageal Varices, Gastrointestinal Hemorrhage, Portal hypertension, Porto-Sinusoidal Vascular disease