Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965232
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2023-07-20
Brief Title:
FIbrosis and Steatosis in Patients With Psychiatric Illness
Sponsor:
Centre Hospitalier Esquirol
Organization:
Centre Hospitalier Esquirol
Study Overview
Official Title:
Screening for Severe Hepatic Fibrosis by FibroScan in a Population Presenting a Severe Psychiatric Disorder Under Treatment for at Least Two Years
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FibroPsy
Brief Summary:
Background Severe psychiatric diseases schizophrenia bipolarity depression anxious syndrome are often associated with a metabolic syndrome including Non-Alcoholic Steato Hepatitis probably misdiagnosed in patients with psychiatric illness Furthermore long-term exposition to substances like alcohol or to one or more psychotropic treatments may involve liver detoxification role Thanks to liver stiffness based on FibroScan and CAP controlled attenuation parameter we wanted to study prevalence of severe fibrosis and steatosis in this population
Material Methods Prospective study of 385 subjects hospitalised in a psychiatric hospital for schizophrenia bipolar disorder depression or anxiety-depression disorder and receiving psychotropic treatment for at least 2 years for whom a FibroScan a blood test and a record of clinical data were carried out after information and informed consent
Benefits expected This study should show an expected excess risk of fibrosis FibroScan in this population and determine the risk factors more associated risk factors Generalized or targeted screening for identified risk factors in this population could help optimize in this population could help optimize the choice and dosage of psychotropic of psychotropic drugs and above all help to guide the strategy of hepatic and prevention strategy
Material Methods Prospective study of 385 subjects hospitalised in a psychiatric hospital for schizophrenia bipolar disorder depression or anxiety-depression disorder and receiving psychotropic treatment for at least 2 years for whom a FibroScan a blood test and a record of clinical data were carried out after information and informed consent
Benefits expected This study should show an expected excess risk of fibrosis FibroScan in this population and determine the risk factors more associated risk factors Generalized or targeted screening for identified risk factors in this population could help optimize in this population could help optimize the choice and dosage of psychotropic of psychotropic drugs and above all help to guide the strategy of hepatic and prevention strategy
Detailed Description:
Patients with psychiatric illness are often exposed to an increase risk of mortality compared to the general population a reduction of life expectancy between 7 and 24 years has been described Somatic illnesses explain 60 of this excess of mortality particularly cardiovascular diseases Notably patients with chronic psychiatric disorders such as depression bipolar disorders or schizophrenia are more frequently exposed to metabolic syndrome A recent meta-analysis showed that patients with severe mental illness had a RR of 158 135-186 of developing metabolic syndrome
Steatosis or fat excess in hepatocytes defines NAFLD non-alcoholic fatty liver disease NAFLD is a spectrum of liver illnesses associated with metabolic syndrome Within NAFLD NASH non-alcoholic steatohepatitis occurs in about 5 of the cases liver inflammation andor fibrosis being associated to steatosis Survival is then impaired notably with a specific risk of cirrhosis in 20 of the patients with NASH and 3 of patients with NAFLD Hepatocarcinoma is a complication of cirrhosis but it may be observed in the absence of cirrhosis in nearly 30 of the cases Its prevalence is progressively increasing from 20 to 27 It will probably be the leading cause of liver transplantation in the next years Otherwise patients with NAFLD are also exposed to non-liver related complications cardiovascular risk is higher in this population and is the main risk of mortality
Although NAFLD is a frequent disease it is yet generally misdiagnosed today essentially because of the lack of symptoms and of systematic screening Furthermore it is key to diagnose the evolutionary stage pure NAFLD NASH and stage of fibrosis The liver biopsy remains the gold standard despite its limitations linked to the sample variability and the differences in interpretation even between expert pathologists
However specific risks associated with this procedure such as bleeding and even a marginal risk of death have been described Furthermore liver biopsy is costly All these arguments explain the difficulty to apply this invasive strategy in screening in the general population Thats why different methods based on non-invasive tests were developed to diagnose fibrosis - the main prognostic factor - and more recently in a more preliminary way to assess steatosis and inflammation Two main methods are used to evaluate fibrosis stage serum biomarkers and liver stiffness Serum biomarkers are non-parametric for example NAFLD fibrosis score Fib4 Forns score and more recently eLIFT or parametric for example FibroTest FibroMeter Liver stiffness is mainly assessed by FibroScan it is easily available and reproducible It was largely validated in different liver diseases including NAFLD Steatosis is simultaneously evaluated thanks to CAP controlled attenuation parameter Strategies based on the associations of different markers have been evaluated to increase sensibility and specificity of each method taken alone to assess fibrosis Specific combinations of elastometry and biomarkers have emerged such as FibroMeterVCTE and FAST
In the psychiatric field NAFLD screening may be important to help to identify patients at liver risk and also at a potential metabolic risk especially since a specific management is available
Even if the association between NAFLD and psychiatric disorders has been described its exact prevalence and impact are not well identified
This is why we aimed to explore the prevalence of liver fibrosis and steatosis in patients with chronic psychiatric illnesses We led a prospective descriptive single-center study in the Esquirol psychiatric hospital in Limoges
Steatosis or fat excess in hepatocytes defines NAFLD non-alcoholic fatty liver disease NAFLD is a spectrum of liver illnesses associated with metabolic syndrome Within NAFLD NASH non-alcoholic steatohepatitis occurs in about 5 of the cases liver inflammation andor fibrosis being associated to steatosis Survival is then impaired notably with a specific risk of cirrhosis in 20 of the patients with NASH and 3 of patients with NAFLD Hepatocarcinoma is a complication of cirrhosis but it may be observed in the absence of cirrhosis in nearly 30 of the cases Its prevalence is progressively increasing from 20 to 27 It will probably be the leading cause of liver transplantation in the next years Otherwise patients with NAFLD are also exposed to non-liver related complications cardiovascular risk is higher in this population and is the main risk of mortality
Although NAFLD is a frequent disease it is yet generally misdiagnosed today essentially because of the lack of symptoms and of systematic screening Furthermore it is key to diagnose the evolutionary stage pure NAFLD NASH and stage of fibrosis The liver biopsy remains the gold standard despite its limitations linked to the sample variability and the differences in interpretation even between expert pathologists
However specific risks associated with this procedure such as bleeding and even a marginal risk of death have been described Furthermore liver biopsy is costly All these arguments explain the difficulty to apply this invasive strategy in screening in the general population Thats why different methods based on non-invasive tests were developed to diagnose fibrosis - the main prognostic factor - and more recently in a more preliminary way to assess steatosis and inflammation Two main methods are used to evaluate fibrosis stage serum biomarkers and liver stiffness Serum biomarkers are non-parametric for example NAFLD fibrosis score Fib4 Forns score and more recently eLIFT or parametric for example FibroTest FibroMeter Liver stiffness is mainly assessed by FibroScan it is easily available and reproducible It was largely validated in different liver diseases including NAFLD Steatosis is simultaneously evaluated thanks to CAP controlled attenuation parameter Strategies based on the associations of different markers have been evaluated to increase sensibility and specificity of each method taken alone to assess fibrosis Specific combinations of elastometry and biomarkers have emerged such as FibroMeterVCTE and FAST
In the psychiatric field NAFLD screening may be important to help to identify patients at liver risk and also at a potential metabolic risk especially since a specific management is available
Even if the association between NAFLD and psychiatric disorders has been described its exact prevalence and impact are not well identified
This is why we aimed to explore the prevalence of liver fibrosis and steatosis in patients with chronic psychiatric illnesses We led a prospective descriptive single-center study in the Esquirol psychiatric hospital in Limoges
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None