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

Hepatocellular Carcinoma Clinical Trial

— SARCOLIVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101758
• Other study ID #: 5855
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Assunta Zocco
• Phone: 063015 1
• Email: Mariaassunta.zocco[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Italy	CEMAD	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Association among sarcopenia and survival or acute decompensation events in patients with liver cirrhosis		24 months
Secondary	To calculate the prevalence of obesity with sarcopenia in patients with non-alcoholic fatty liver disease		24 months
Secondary	To evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma		24 months
Secondary	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