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

Prospective Study of Ultrasound Assessment of Sarcopenia and Correlated Clinical Outcomes in Patients With Chronic Liver Disease: the SARCOLIVER Study

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Assunta Zocco; Phone Number: 063015 1; Email: Mariaassunta.zocco@policlinicogemelli.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Recruiting
      • CEMAD
      • Contact: Maria Assunta Zocco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: Muscular ultrasound assessment; Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma

Diagnostic test: Handgrip strength test; A handgrip strength test using a hydraulic hand dynamometer will be performed; Diagnostic test: total body Dual Energy X-Ray Absorptiometry (DXA); A total body Dual Energy X-Ray Absorptiometry (DXA) to estimate muscle mass will be performed; Diagnostic test: Muscle ultrasound; A muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma	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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Fibrosis; Muscular Atrophy; Atrophy; Liver Diseases; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Sarcopenia
• Other Study ID Numbers: 5855

Drug and device information, study documents

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