Status:
NOT_YET_RECRUITING
Building of Prognosis Model for Patients With Cirrhosis Based on Sarcopenia Assessed by Deep Learning
Lead Sponsor:
Peking University People's Hospital
Conditions:
Cirrhosis, Liver
Sarcopenia
Eligibility:
All Genders
18+ years
Brief Summary
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 prognos...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 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) \> 2.
- Availability of high-quality L3-level CT images
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06531200
Start Date
September 1 2024
End Date
December 31 2025
Last Update
August 6 2024
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