TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: TIPS, Portal Hypertension, Porto-Sinusoidal Vascular Disease, Refractory Ascite. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
TIPS for the Management of Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Overview
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
Primary outcome measures
- overall survival after TIPS placement [Time frame: at 3 months]
- overall survival after TIPS placement [Time frame: at 6 months]
- overall survival after TIPS placement [Time frame: at 1 year]
- overall survival after TIPS placement [Time frame: at 2 years]
- overall survival after TIPS placement [Time frame: at 3 years]
- overall survival after TIPS placement [Time frame: at 4 years]
- overall survival after TIPS placement [Time frame: at 5 years]
Secondary outcome measures (12)
- free portal hypertension hemorrhage recurrence survival [Time frame: at 3 months]
- free portal hypertension hemorrhage recurrence survival [Time frame: at 6 months]
- free portal hypertension hemorrhage recurrence survival [Time frame: at 1 year]
- free portal hypertension hemorrhage recurrence survival [Time frame: at 2 years]
- free portal hypertension hemorrhage recurrence survival [Time frame: at 3 years]
- free portal hypertension hemorrhage recurrence survival [Time frame: at 4 years]
- free portal hypertension hemorrhage recurrence survival [Time frame: at 5 years]
- free ascite recurrence survival [Time frame: at 3 months]
- free ascite recurrence survival [Time frame: at 6 months]
- free ascite recurrence survival [Time frame: at 1 year]
- free ascite recurrence survival [Time frame: at 2 years]
- free ascite recurrence survival [Time frame: at 3 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- CHU Amiens Picardie — Amiens
Identifiers
NCT: NCT07163689 · PI2025_843_0102