Study Protocol to Redefine Muscle Attenuation Cut-offs for Better Prediction of Mortality in Patients with Cirrhosis: a Comprehensive Post-hoc Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,296
- 试验地点
- 1
- 主要终点
- Definition of new L3/L3-L4 muscle attenuation cut-offs to define myosteatosis in relation to risk of death in patients with cirrhosis
研究概览
简要总结
The goal of this observational study is to learn if new muscle attenuation cut-offs for the definition of myosteatosis can better predict survival in patients with cirrhosis. The main questions it aims to answer are:
- Can these new muscle attenuation cut-offs more accurately diagnose myosteatosis (fat infiltration in muscle mass ) in cirrhosis?
- Do these cut-offs work effectively across different patient groups, including men and women, those with obesity, and those with fluid retention in the abdomen?
Researchers will compare patients with cirrhosis from a retrospective Canadian cohort to those from a prospective Italian cohort to see if the new cut-offs predict survival better than existing ones**.
Due to the retrospective nature of the study, no action is required from participants.
详细描述
Detailed Description This observational study seeks to redefine muscle attenuation cut-offs to better predict mortality in patients with cirrhosis, particularly focusing on myosteatosis-a condition characterized by the pathological accumulation of fat within skeletal muscles. Myosteatosis is a critical factor in cirrhosis, associated with poor outcomes, including increased risk of overt hepatic encephalopathy, prolonged hospitalization, post-transplant complications, and reduced survival. The current cut-offs for diagnosing myosteatosis are derived from studies in oncology populations, which may not be appropriate for cirrhosis patients due to specific complications like fluid retention (ascites) and differences in fat and muscle distribution between genders.
Background and Rationale Cirrhosis patients often experience muscle changes due to chronic inflammation and metabolic disturbances, leading to muscle fat infiltration or myosteatosis. This study builds on previous research by Ebadi et al., who proposed sex-specific cut-offs (<33 HU for men and <28 HU for women) for diagnosing myosteatosis based on muscle attenuation values measured via CT scans. However, these cut-offs were derived from a retrospective cohort and have not been validated externally. There is a clear need for liver-specific cut-offs that account for the unique characteristics of cirrhosis, including the impact of fluid retention on BMI and muscle attenuation measurements.
Study Objectives
The primary objective is to validate new muscle mass attenuation cut-offs for the diagnosis of myosteatosis using L3 CT scan evaluations to predict survival and outcomes in patients with cirrhosis. Secondary objectives include:
- Assessing the accuracy of these cut-offs across different patient groups (e.g., by gender, obesity status, and presence of ascites).
- Evaluating the prognostic significance of redefined myosteatosis when combined with sarcopenia (muscle wasting).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective cohort:
- •Clinical, radiological and/or histological diagnosis of cirrhosis
- •Abdominal CT-scan obtained as part of the LT evaluation
- •Prospective cohort:
- •Clinical, radiological and/or histological diagnosis of cirrhosis
- •Age 40-75 years
- •Abdominal CT-scan
排除标准
- •Retrospective cohort:
- •Multi-organ transplantation
- •Re-transplantation
- •Prospective cohort:
- •Patient on LT waiting lists
- •Hepatocellular carcinoma (HCC)
- •History of LT
- •Concomitant neuromuscular disease
- •Current malignancy other than non-melanocytic skin cancer
- •History of serious extrahepatic disease
- •HIV infection.
结局指标
主要结局
Definition of new L3/L3-L4 muscle attenuation cut-offs to define myosteatosis in relation to risk of death in patients with cirrhosis
时间窗: 12 months
The primary outcome is the validation of L3 / L3-L4 muscle attenuation values associated with the overall risk of death. Liver transplantation will be considered as a competing event in any analysis of the clinical impact of muscle damage, according to the above definition and classification.
次要结局
- Association of newly defined myosteatosis with risk of clinical events in patients with cirrhosis(12 months)
研究者
Simone Di Cola
Medical Doctor
University of Roma La Sapienza