Ultrasound Assessment of Sarcopenia in Patients With Chronic Liver Disease: the SARCOLIVER Study

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Liver Cirrhosis; Hepatocellular Carcinoma; Non-Alcoholic Fatty Liver Disease

Treatments: Diagnostic Test: Handgrip strength test; Diagnostic Test: Muscle ultrasound; Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06101758

5855

Details and patient eligibility

About

Sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). Even if in patients with chronic liver disease an association among sarcopenia and poor clinical outcomes is well known, the data available about the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma are very variable according to the populations in object and, furthermore, few data are available regarding the use of muscular ultrasound to detect this condition. The aim of this study is to define the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma in follow-up at our center and the clinical outcomes associated with this condition, and to determine the reliability of muscular ultrasound to diagnose the condition of sarcopenia through a comparison with other validated techniques such as computed tomography, magnetic resonance imaging and dual-energy X-ray absorptiometry.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to express informed consent
• Diagnosis of liver cirrhosis or non-alcoholic fatty liver disease or hepatocellular carcinoma based on clinical characteristics, biochemical serum tests and liver imaging examination or liver histologic examination if available

Exclusion criteria

• inability to express informed consent
• pregnancy
• presence of a concomitant oncologic disease different from hepatocellular carcinoma
• presence of a concomitant gastrointestinal disease able to influence the absorption and digestion of nutrients (e.g. inflammatory bowel disease, celiac disease, short-bowel syndrome, congenital defects of metabolism)
• presence of a concomitant gastrointestinal or neurologic disease able to influence the ability of feeding (e.g. dysphagia, parkinson disease, neuromuscular diseases, diseases of the autonomic nervous system, cognitive impairment or dementia)
• chronic kidney disease from stage 3 B (IIIB) according to Kidney Disease: Improving Global Outcomes (KDIGO) classification (eGFR <45ml/min/1.73m2)
• chronic heart failure from stage Ney York Heart Association (NYHA) II
• concomitant infection from Mycobacterium Tuberculosis or human immunodeficiency virus or chronic parasitic infections

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Muscular ultrasound assessment

Experimental group

Description:

Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma

Treatment:

Diagnostic Test: Handgrip strength test

Diagnostic Test: Muscle ultrasound

Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA)