Prospective Study of Ultrasound Assessment of Sarcopenia and Correlated Clinical Outcomes in Patients With Chronic Liver Disease: the SARCOLIVER Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma
时间窗: 24 months
次要结局
- 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)
研究者
Zocco Maria Assunta
Prof
Fondazione Policlinico Universitario Agostino Gemelli IRCCS