TIPS for Complicated Portal Hypertension Related to Porto-Sinusoidal Vascular Disease
Recruiting now
Conditions studied: TIPS, Portal Hypertension, Porto-Sinusoidal Vascular Disease, Refractory Ascite, Esophageal Varices, Gastrointestinal Hemorrhage
In brief
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
Key facts
- Study ID
- NCT07163689
- Run by
- Centre Hospitalier Universitaire, Amiens
- People needed
- 360
- Starts
- 2025-05-16
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- CHU Amiens Picardie — Amiens, Picardie, France (enrolling)
Full record on ClinicalTrials.gov
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