Building of Prognosis Model for Patients With Cirrhosis Based on Sarcopenia in Assessment With the Technology of Deep Learning
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Liver-related mortality
研究概览
简要总结
The goal of this observational study is to develop and validate a fully automated imaging deep learning platform for the evaluation of sarcopenia in liver cirrhosis. Based on this model, a new prognostic model for liver cirrhosis incorporating imaging biomarkers such as sarcopenia will be constructed, and its predictive performance will be validated.
详细描述
The goal of this observational study is to collect clinical and abdominal imaging data of patients with liver cirrhosis. The collected imaging data will be used as a model development set to develop, test, and internally validate a fully automated imaging deep learning platform for the evaluation of sarcopenia in liver cirrhosis. Subsequently, relevant data from patients with liver cirrhosis at other centers will be collected and used as an external validation dataset. The model will be externally validated by abdominal radiology experts. Furthermore, we will include sociodemographic information, clinical data, imaging data, and clinical outcomes of the aforementioned liver cirrhosis patients to predict the prognosis of these patients using the established model. This model will be used to construct a new prognostic model for liver cirrhosis incorporating imaging biomarkers such as sarcopenia, and its predictive performance will be validated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of liver cirrhosis, meeting at least one of the following criteria:
- •Clinical diagnosis: ICD-10-CM codes K74.100 and K74.607 from our hospital's electronic medical record system
- •Liver biopsy pathology or a combination of clinical, laboratory, and imaging examinations confirming liver cirrhosis: Pathological biopsy criteria: fibrosis bridging between lobules leading to lobular structural disarray, nodular regeneration of hepatocytes, formation of pseudo-lobules
- •Laboratory tests: the presence of at least 2 of the following 4 abnormal indicators suggesting liver cirrhosis:
- •a) Platelet count < 100×10^9/L, with no other explainable cause;
- •b) Serum albumin < 35g/L, excluding malnutrition or kidney disease as other causes;
- •c) International normalized ratio (INR) > 1.3 or prolonged prothrombin time (PT) (after discontinuation of thrombolytic or anticoagulant drugs for more than 7 days);
- •d)Aspartate aminotransferase to platelet ratio index (APRI) >
- •Availability of high-quality L3-level CT images
排除标准
- •Incomplete sociodemographic, laboratory, or imaging data
- •Diagnosed or highly suspected malignancy
- •Severe chronic kidney disease, respiratory insufficiency, cardiovascular diseases, etc.
- •Neurological diseases and muscular degenerative diseases
- •Hyperthyroidism, hypothyroidism, tuberculosis, or any other diseases that may affect basal metabolism
- •Diseases or conditions causing malabsorption of intestinal nutrients, such as inflammatory bowel disease or gastrointestinal surgery
- •Treatment with glucocorticoids or immunosuppressants
- •Pregnancy or lactation
结局指标
主要结局
Liver-related mortality
时间窗: As of December 31, 2025
Causes of liver disease-related mortality include: Hepatitis B virus infection, hepatitis C virus infection, alcohol-induced or toxic liver disease; complications related to liver cirrhosis: ascites or pleural effusion, esophagogastric variceal bleeding, spontaneous bacterial peritonitis or related infections, hepatic encephalopathy or other neuropsychiatric syndromes based on metabolic disorders, hepatorenal syndrome, hepatopulmonary syndrome; liver failure; hepatocellular carcinoma; death or liver transplantation.
次要结局
- All-cause Mortality(As of December 31, 2025)
研究者
Huang Rui
Principal Investigator
Peking University People's Hospital