Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study - a study protocol.

Abstract

Introduction: 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).

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: NCT06593015.