TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
| Registry | NCT07163689, acronym TIPS-PSVD |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 360 (Estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens (Other); collaborators: Groupe Hospitalier Pitie-Salpetriere, Rennes University Hospital, AP-HP - HU BEAUJON, University Hospital, Toulouse, CHRU TOURS, Centre Hospitalier Universitaire de Besancon, Hospices Civils de Lyon, France, APHP - HOPITAL AVICENNE, University Hospital, Montpellier, Saint-Luc University Hospital, CHU Poitiers, Centre Hospitalier Universitaire de Nice, CH HENRI MONDOR, Saint Antoine University Hospital, University Hospital, Rouen, Hopital Paul Brousse, Nantes University Hospital, Centre Hospitalier Universitaire Dijon, University Hospital, Bordeaux, University Hospital, Brest, University Hospital, Clermont-Ferrand |
| Conditions | TIPS, Portal Hypertension, Porto-Sinusoidal Vascular Disease, Refractory Ascite, Esophageal Varices, Gastrointestinal Hemorrhage |
| Dates | start 2025-05-16, primary completion 2025-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2025-09-09, last updated 2025-11-19 |
| Locations | 1 site in France |
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All trials for TIPS All trials for Portal Hypertension
Porto-sinusoidal Vascular Disease (PSVD) is characterized by a portal hypertension (PH) without cirrhosis. This can induce PH complications, like digestive hemorrhage from esophageal or gastric varices, ascites, or even portal thrombosis. Due to the rarity of MVPS, the treatment of complications of portal hypertension is modeled on the methods used in cirrhotic portal hypertension with non-cardio-selective beta blockers, endoscopic ligations or diuretics in first line therapy, as proposed by the Baveno VII recommendations. In complicated or refractory forms of PH in PSVD, the place of TIPS is also discussed, as in the field of cirrhosis. However, the experience of TIPS in PSVD is limited, reported in case reports and small specifically dedicated series. No predictive factors for survival or recurrence and tolerance were well known. A larger study with control group is needed in order to better know the right time and the right indication for the use of TIPS in complicated PH PSVD-related.
The study will be retrospective, multicentric involving tertiary university French centers, expert in the management of TIPS. Patients white TIPS-PSVD will be compared with historical patients with TIPS-cirrhose, matched on age, sexe, indication of TIPS. The study will not comprise new intervention, only observational in a real life condition
| Arm | Type | Interventions | Description |
|---|---|---|---|
| group TIPS-PSVD | experimental group | ||
| TIPS-cirrhose | historical control group |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| CHU Amiens Picardie | Amiens, Picardie | France | Recruiting |