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

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Non-Alcoholic Fatty Liver Disease; Liver Cirrhosis
• Interventions: Diagnostic Test: Handgrip strength test; Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA); Diagnostic Test: Muscle ultrasound

• Registration Number: NCT06101758
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-04
• Status Verified: 2023-10
• Study Start: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscular ultrasound assessment	total body Dual Energy X-Ray Absorptiometry (DXA)	Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma
Muscular ultrasound assessment	Handgrip strength test	Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma
Muscular ultrasound assessment	Muscle ultrasound	Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma

Primary Outcome Measures

Name	Time	Method
To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma	24 months

Secondary Outcome Measures

Name	Time	Method
Association among sarcopenia and survival or acute decompensation events in patients with liver cirrhosis	24 months
To calculate the prevalence of obesity with sarcopenia in patients with non-alcoholic fatty liver disease	24 months
To calculate cohen's Kappa to evaluate the concordance among muscular ultrasound and dual-energy X-ray absorption, computed tomography scan and magnetic resonance imaging in the detection of sarcopenia	24 months
To evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma	24 months

Trial Locations

Locations (1)

CEMAD; 🇮🇹 Roma, RM, Italy