PortoSinusoidal Vascular Diseases and Systemic Sclerosis

NCT ID: NCT06032754

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-03-29

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.

Conditions

PSVD With or Without SSc

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

First group : SSC with PSVD

medical file analysis of patients affected by SSC and PSVD

No interventions assigned to this group

Second group : PSVD without SSC

medical file analysis of patients affected by PSVD only

No interventions assigned to this group

Third group : SSC without PSVD

medical file analysis of patients affected by SSC only

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• PSVD (Valdig criteria)
• SSC (ACR/EULAR 2013 criteria)

Exclusion Criteria

• Liver cirrhosis
• Limited scleroderma
• Autoimmune hepatitis
• Primary biliary cholangitis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu de Caen

Caen, Calvados, France

Countries

France

Other Identifiers

MVPScS

Identifier Type: -

Identifier Source: org_study_id