Di Cola Simone, D'Amico Gennaro, Motamedrad Maryam, Montano-Loza Aldo, Merli Manuela
Department of Translational and Precision Medicine, University of Rome La Sapienza, Rome, Lazio, Italy.
Gastroenterology, Ospedale V Cervello, Palermo, Italy.
BMJ Open. 2025 Mar 25;15(3):e094252. doi: 10.1136/bmjopen-2024-094252.
Myosteatosis, characterised by altered muscle composition detectable by muscle radiodensity attenuation on CT scans, has been associated with increased mortality in patients with cirrhosis. However, standard attenuation cut-offs, derived primarily from oncology populations, may not be appropriate for patients with cirrhosis. This study protocol aims to address this diagnostic gap by validating the Ebadi cut-offs, which are based on a retrospective cohort and have not been extensively validated in a cirrhotic population. The aim of the study is to refine these cut-offs for more accurate prediction of mortality in patients with cirrhosis using two independent patient cohorts (retrospective and prospective).
This post hoc validation study analyses muscle weakness cut-offs in patients with cirrhosis using data from two independent cohorts. A total of 1537 patients will be analysed. The study will assess interobserver variability to ensure robust results by analysing random samples of 60 patients from the two cohorts. Statistical methods will be used to determine the accuracy and relevance of current cut-offs in predicting patient mortality. The analysis will also examine the relationship between muscle wasting and clinical outcomes in cirrhosis and the relationship with muscle mass loss.
Ethical approval for this study has been obtained from the relevant institutional review boards. The results will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. The results of the study are expected to contribute to improved diagnostic criteria for myosteatosis in cirrhosis, providing clinicians with more tailored and accurate tools for cirrhosis prognosis.
NCT06593015.
肌脂肪变性的特征是通过CT扫描上肌肉放射密度衰减可检测到肌肉组成改变，它与肝硬化患者死亡率增加有关。然而，主要源自肿瘤学人群的标准衰减临界值可能不适用于肝硬化患者。本研究方案旨在通过验证埃巴迪临界值来填补这一诊断空白，该临界值基于回顾性队列研究，尚未在肝硬化人群中得到广泛验证。本研究的目的是使用两个独立的患者队列（回顾性和前瞻性）来完善这些临界值，以便更准确地预测肝硬化患者的死亡率。
这项事后验证研究使用来自两个独立队列的数据，分析肝硬化患者的肌肉无力临界值。总共将分析1537名患者。该研究将通过分析两个队列中60名患者的随机样本，评估观察者间的变异性，以确保结果的可靠性。将使用统计方法来确定当前临界值在预测患者死亡率方面的准确性和相关性。分析还将检查肝硬化中肌肉消耗与临床结局之间的关系以及与肌肉量减少的关系。
本研究已获得相关机构审查委员会的伦理批准。研究结果将通过在科学会议上的报告以及在同行评审期刊上发表进行传播。预计该研究结果将有助于改进肝硬化中肌脂肪变性的诊断标准，为临床医生提供更具针对性和准确性的肝硬化预后评估工具。
NCT06593015。
