TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
NCT07163689 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 360
Last updated 2025-11-19
Summary
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
Conditions
- TIPS
- Portal Hypertension
- Porto-Sinusoidal Vascular Disease
- Refractory Ascite
- Esophageal Varices
- Gastrointestinal Hemorrhage
Sponsors & Collaborators
-
Groupe Hospitalier Pitie-Salpetriere
collaborator OTHER -
CHU Rennes
collaborator UNKNOWN -
AP-HP - HU BEAUJON
collaborator UNKNOWN -
University Hospital, Toulouse
collaborator OTHER -
CHRU TOURS
collaborator UNKNOWN -
Centre Hospitalier Universitaire de Besancon
collaborator OTHER -
Hospices Civils de Lyon, France
collaborator UNKNOWN -
APHP - HOPITAL AVICENNE
collaborator UNKNOWN -
University Hospital, Montpellier
collaborator OTHER -
Saint-Luc University Hospital
collaborator UNKNOWN -
CHU Poitiers
collaborator UNKNOWN -
CHU NICE
collaborator UNKNOWN -
CH HENRI MONDOR
collaborator UNKNOWN -
Saint Antoine University Hospital
collaborator OTHER -
University Hospital, Rouen
collaborator OTHER -
AP-HP Paul Brousse University Hospital
collaborator UNKNOWN -
Nantes University Hospital
collaborator OTHER -
Centre Hospitalier Universitaire Dijon
collaborator OTHER -
University Hospital, Bordeaux
collaborator OTHER -
University Hospital, Brest
collaborator OTHER -
University Hospital, Clermont-Ferrand
collaborator OTHER -
Centre Hospitalier Universitaire, Amiens
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-16
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- France
Study Locations
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