Clinical trial NCT06838468: cACLD in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit
Official title: Detection of Advanced Chronic Liver Disease in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Disease Chronic
Cirrhosis
Detoxification
Alcohol Abuse/Dependence
Keywords: chronic advance liver disease
detoxification unit
elastography
liver risk score
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the detoxification unit for alcohol use disorder or de psychiatry unit for dual pathology with harmful alcohol consumption

Brief summary: The aim of this study is to conduct a quick assessment of potential liver damage caused by chronic alcohol consumption. Taking advantage of the patient's admission to a specialized detoxification unit, several tests will be performed to determine the extent of liver damage through blood tests, ultrasound, and FibroScan

Detailed description: There is very little recent data on the prevalence of advance chronic liver disease in high-risk patients, particularly in our region, making studies evaluating this necessary.

In the European clinical practice guidelines (EASL Clinical Practice Guidelines: Management of Alcohol-Related Liver Disease), it is recommended to screen for advance chronic liver disease in high-risk populations such as patients in rehabilitation and detox clinics and heavy drinkers. advance chronic liver disease should be considered in patients presenting with extrahepatic manifestations of alcohol use disorder, such as peripheral symmetric neuropathy, pancreatitis, and cardiomyopathy, among others.

Screening for liver disease in high-risk groups should not only include liver function tests (e.g., gamma-glutamyl transferase \[GGT\], alanine aminotransferase \[ALT\], or aspartate aminotransferase \[AST\]) but also include testing for liver fibrosis (e.g., transient elastography such as FibroScan®), given that advanced liver disease may occur in patients with normal liver profiles.

If any abnormalities are detected in liver profiles or elastography, an abdominal ultrasound should be performed to rule out hepatocellular carcinoma and a complete liver disease study should be carried out to exclude alternative or additional causes of liver damage. Current clinical guidelines (Spanish, European, and American) do not specify which tools to use in each risk subgroup.

The primary objective is to assess the prevalence of advance chronic liver disease measured by transient elastography in patients admitted to the Hospital Detoxification Unit and the acute psychiatric unit with dual pathology and harmful alcohol consumption.

This is a prospective, descriptive, single-center study conducted at Hospital Parc Taulí in Sabadell on patients admitted to the Hospital Detoxification Unit and the psychiatric unit with a diagnosis of dual pathology and harmful alcohol consumption. The study duration will be one year (from June 2024 to June 2025).

We will obtein clinical Variables like date of birth, sex, ethnicity, height, height, medical history (e.g., diagnosis of diabetes, dyslipidemia, hypertension, or underlying psychiatric disorder); Laboratory Variables: ALT, AST, alkaline phosphatase (ALP), GGT, total bilirubin, INR, platelets, glucose, HbA1c, total cholesterol, HDL, LDL, TSH, ferritin, and transferrin saturation. For patients with abnormal liver profiles, a second etiological study will be performed, including ceruloplasmin, copper, alpha-1 antitrypsin, ANA and SLA autoantibodies, immunoglobulins (IgA, IgG, IgM), and protein electrophoresis.

Elastography Variables: FibroScan® values and CAP (Control Attenuation Parameter) to estimate liver stiffness and quantify hepatic fat, respectively.

Radiological Variables: Abdominal ultrasound findings (e.g., homogeneous or heterogeneous liver, presence of steatosis, nodular liver borders, splenomegaly, recanalization of the paraumbilical vein, collateral circulation, portal velocity, hepatic nodules). Endoscopic Variables: For patients diagnosed with advance chronic liver disease, esophagogastroduodenoscopy will be performed to rule out esophageal varices if criteria are met. Serological Variables for Fibrosis Estimation: LiverRisk score, APRI, FIB-4, Forns index, AAR (AST to ALT ratio).

Regardless of liver profile abnormalities, an abdominal ultrasound will be requested to evaluate parenchymal changes and other indirect signs of liver disease and/or portal hypertension. Additional data collected by psychiatry will include the patient's date of birth, years of alcohol consumption, grams of alcohol/day measured in Standard Drink Units (SDUs), weight, height, relevant cardiovascular diseases (hypertension, diabetes, dyslipidemia), and underlying psychiatric disorders.

A hepatology consultation will be requested, and FibroScan® will be performed during hospitalization. All fibrosis scores (LiverRisk score, APRI, FIB-4, Forns, and AAR) will be calculated using demographic and laboratory data.

If liver profile abnormalities are detected upon admission, a complete second etiological study will be requested.

All patients, regardless of whether they have advanced chronic liver disease or not, will be evaluated by a hepatologist who will provide information about the results of the diagnostic tests performed and the potential harmful effects of alcohol on the liver and overall health. This will reinforce the information provided by the psychiatrist in an effort to encourage the patient to cease alcohol consumption.

If the patient presents advance chronic liver disease (FibroScan® \>8 KPa) or analytical, elastographic, or radiological evidence suggestive of cirrhosis will be referred to hepatology outpatient clinics for further evaluation and follow-up. Patients without advance chronic liver disease findings will be referred to primary care by their attending psychiatrist for follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the detoxification unit for alcohol use disorder
* Patients admitted to the psychiatry unit for dual pathology with harmful alcohol consumption (\> 30 g/day in men (3 standard drinks) and \> 20 g/day in women (2 standard drinks))

Exclusion Criteria:

* Refusal to undergo additional tests (blood analysis, ultrasound, and FibroScan)

Primary outcomes:
measure: Prevalence of advanced chronic liver disease in patients who are electively admitted to the hospital alcohol detoxification unit
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Consorci Corporació Sanitària Parc Taulí
state: Barcelona
Study officials:
affiliation: Consorci Corporació Sanitària Parc Taulí
name: Jordi Sánchez Delgado, MD. PhD
role: PRINCIPAL_INVESTIGATOR
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