PortoSinusoidal Vascular Diseases and Systemic Sclerosis
- Conditions
- PSVD With or Without SSc
- Registration Number
- NCT06032754
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.
- Detailed Description
The study aims to compare the outcome of patients with MVPS associated with SSc to patients with MVPS without SSc. This work is a multicenter retrospective study comparing two groups of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc. Patients with MVPS associated with SSc will be recruited from French university hospital departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- PSVD (Valdig criteria)
- SSC (ACR/EULAR 2013 criteria)
- Liver cirrhosis
- Limited scleroderma
- Autoimmune hepatitis
- Primary biliary cholangitis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prognosis 2 years To compare prognosis of PSVD patients with or without SSc (less or more gastrointestinal bleeding/portal vein thrombosis)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chu de Caen
🇫🇷Caen, Calvados, France