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

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

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.

Study Overview

• Status: Completed
• Conditions: Psychiatric Disorder; Liver Fibrosis; Advanced Chronic Liver Disease; Psychiatric Hospitalization
• Intervention / Treatment: Diagnostic test: non invasive evaluation of liver fibrosis by transient elastography (Fibroscan ®)

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acceptability of non invasive assessement of liver fibrosis by Fibroscan in psychiatric patients	Number of patient who have agreed to do fibroscan screening among patient to whom it was offered.	At Inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of advanced liver disease in psychiatric patients	Number of patient who are diagnosed with advanced liver disease among patient to whom it was offered.	At inclusion
prevalence of excessive alcohol or drug consumption in psychiatric patients	Number of patient with excessive alcohol/drug consumption	At inclusion
prevalence of passed or active drug consumption (intraveinous, inhaled or sniffed) in psychiatric patients	Number of patient with excessive alcohol/drug consumption	At Inclusion
prevalence of viral hepatitis in psychiatric patients	Number of patient diagnosed with viral hepatitis B, D, C	At Inclusion
correlation between advanced chronic liver diseases and risk factors for liver diseases in psychiatric patients	Number of patients with advanced chronic liver disease among those having risk factors for chronic liver disease	1 to 3 month after inclusion
assessment of referral to medical care when advanced fibrosis was diagnosed, regardless of its etiology	Number of patients that have actually came to their medical appoint after advanced fibrosis diagnosis	1 to 3 month after inclusion
reason for refusal of non invasive evaluation of chronic liver disease	rate of reasons of refusal according to reason of hospitalization, sector, duration of hospitalization, time spend in study explaination, patient reflection time	At Inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: psychiatric disorders; alcoholic liver diseases; advanced liver disease; viral hepatitis; transient elastography (Fibroscan ®)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Problem Behavior; Mental Disorders; Liver Cirrhosis
• Other Study ID Numbers: RECHMPL22_0114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No