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CompletedNCT06032754Updated Jun 20, 2024

PortoSinusoidal Vascular Diseases and Systemic Sclerosis

An observational study in PSVD With or Without SSc, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by University Hospital, Caen · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • PSVD With or Without SSc

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Keywords

  • Porto-Sinusoidal Vascular Disease
  • Nodular regenerative hyperplasia
  • Systemic sclerosis
03

In context

Scleroderma, Systemic

695 studies on the registry are indexed under Scleroderma, Systemic; 224 are open to participants now.

This study's enrollment of 180 is above the median of 100 across 171 observational studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 510 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

3 types of patients : PSVD with SSC, PSVD without SSC, SSC without PSVD will be compared.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Liver cirrhosis
  • Limited scleroderma
  • Autoimmune hepatitis
  • Primary biliary cholangitis
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • First group : SSC with PSVD

    medical file analysis of patients affected by SSC and PSVD

  • Second group : PSVD without SSC

    medical file analysis of patients affected by PSVD only

  • Third group : SSC without PSVD

    medical file analysis of patients affected by SSC only

06

What researchers measure

Primary outcomes

  1. Prognosis

    To compare prognosis of PSVD patients with or without SSc (less or more gastrointestinal bleeding/portal vein thrombosis)

    Time frame: 2 years

07

Study locations

1 site
  • Chu de Caen
    Caen, Calvados 14000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06032754
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Feb 1, 2023
Primary completion
Mar 29, 2024
Completion
Mar 29, 2024
Last update
Jun 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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