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NCT Number: NCT05602870

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

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.

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Key information

Conditions

Psychiatric Disorder Advanced Chronic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Liver Diseases, Alcoholic Liver Fibrosis Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Psychiatric Hospitalization Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital

Montpellier, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)

Diagnostic Test

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.

Primary outcomes

  1. acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients

    Time frame: At Inclusion

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

Secondary outcomes

  1. Prevalence of advanced liver disease in psychiatric patients

    Time frame: 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

    Time frame: 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

    Time frame: At Inclusion

    Number of patient with excessive alcohol/drug consumption

  4. prevalence of viral hepatitis in psychiatric patients

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: At Inclusion

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Acceptability of Advanced Chronic Liver Disease Screening by Transient Elstography (Fibroscan ®) in Patients Hospitalised in Psychiatric Unit: a Single Center Prospective Study

Acronym: HEPSY

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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