HEPSY: Advanced Chronic Liver Disease Screening by Transient Elstography in Patients Hospitalised in a Psychiatric Unit

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05602870
Collaborator
(none)
180
1
1
24
7.5

Study Details

Study Description

Brief Summary

Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders.

There are still many barriers to screening and linkage to care for patients having somatic illness.

Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs.

The aim of this study is to asses acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in a psychiatric unit.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)
N/A

Detailed Description

Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders.

There are still many barriers to screening and linkage to care for patients having somatic illness.

Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs.

Transient elastography is a useful tool validated for early diagnosis advanced chronic liver disease.It is non-invasive, fast, and gives immediate results.

The aim of this study is to assess acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in psychiatric unit.

Moreover, we will estimate de prevalence of advanced chronic liver diseases according to specific causes in psychiatry unit We hypothesize that the fact of offering psichiatric patents a non-invasive analysis of hepatic fibrosis will improve the detection of serious liver diseases and linkage to care.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Acceptability of Advanced Chronic Liver Disease Screening by Transient Elstography (Fibroscan ®) in Patients Hospitalised in Psychiatric Unit: a Single Center Prospective Study
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Psychiatric patient

All patients having psychiatric disorders and hospitalised in a Psychiatry Unit of CHU Montpellier will have an non invasive evaluation of liver fibrosis after giving their consent

Diagnostic Test: non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)
A Fibroscan will be performed and the result will be given to the patient. A follow-up will be organized in the event of a diagnosis of severe fibrosis. If the serologies for hepatitis B and C cannont be recovered, patient will be able to benfit from a rapid diagnostic orientation test (TROD) (minimally invasive capillary venous sampling at the fingertip) for these 2 serologies.

Outcome Measures

Primary Outcome Measures

  1. acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients [At Inclusion]

    Number of patient who have agreed to do fibroscan screening among patient to whom it was offered.

Secondary Outcome Measures

  1. Prevalence of advanced liver disease in psychiatric patients [At inclusion]

    Number of patient who are diagnosed with advanced liver disease among patient to whom it was offered.

  2. prevalence of excessive alcohol or drug consumption in psychiatric patients [At inclusion]

    Number of patient with excessive alcohol/drug consumption

  3. prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients [At Inclusion]

    Number of patient with excessive alcohol/drug consumption

  4. prevalence of viral hepatitis in psychiatric patients [At Inclusion]

    Number of patient diagnosed with viral hepatitis B, D, C

  5. correlation between advanced chronic liver diseases and risk factors for liver diseases in psychiatric patients [1 to 3 month after inclusion]

    Number of patients with advanced chronic liver disease among those having risk factors for chronic liver disease

  6. assessment of referral to medical care when advanced fibrosis was diagnosed, regardless of its etiology [1 to 3 month after inclusion]

    Number of patients that have actually came to their medical appoint after advanced fibrosis diagnosis

  7. reason for refusal of non invasive evaluation of chronic liver disease [At Inclusion]

    rate of reasons of refusal according to reason of hospitalization, sector, duration of hospitalization, time spend in study explaination, patient reflection time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion criteria

  • adults ≥18 years

  • having a psychiatric condition and hospitalized in a psychiatry unit of CHU Montpellier , France

  • patients who lack capacity of consent if legal representative consents

  • involuntary psychiatric hospitalization, if consent is given

Exclusion criteria

  • lack of written consent

  • Unable to understand nature and objective of the methodology

  • Pregnant or breast feeding woman

  • Not affiliated with a French social security

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montpellier University Hospital Montpellier France

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT05602870
Other Study ID Numbers:
  • RECHMPL22_0114
First Posted:
Nov 2, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2022