TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Amiens Picardie
RECRUITING
Amiens
Contact Information
Primary
Eric NGUYEN-KHAC, Pr
nguyen-khac.eric@chu-amiens.fr
33+3 22 08 88 51
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2025-11
Participants
Target number of participants: 360
Treatments
group TIPS-PSVD
experimental group
TIPS-cirrhose
historical control group
Sponsors
Collaborators: CHU NICE, CH HENRI MONDOR, CHU Rennes, University Hospital, Montpellier, CHRU TOURS, APHP - HOPITAL AVICENNE, Nantes University Hospital, CHU Poitiers, Centre Hospitalier Universitaire Dijon, Saint Antoine University Hospital, University Hospital, Clermont-Ferrand, Groupe Hospitalier Pitie-Salpetriere, University Hospital, Brest, AP-HP Paul Brousse University Hospital, Centre Hospitalier Universitaire de Besancon, Hospices Civils de Lyon, France, University Hospital, Toulouse, University Hospital, Bordeaux, AP-HP - HU BEAUJON, University Hospital, Rouen, Saint-Luc University Hospital
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov

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