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Building of Prognosis Model for Patients With Cirrhosis Based on Sarcopenia Assessed by Deep Learning

Building of Prognosis Model for Patients With Cirrhosis Based on Sarcopenia in Assessment With the Technology of Deep Learning

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06531200
Enrollment
1000
Registered
2024-07-31
Start date
2024-09-01
Completion date
2025-12-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver, Sarcopenia

Keywords

deep learning, prognosis, sarcopenia, myosteatosis

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 prognostic model for liver cirrhosis incorporating imaging biomarkers such as sarcopenia will be constructed, and its predictive performance will be validated.

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, 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.

Interventions

None listed

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Liver-related mortalityAs of December 31, 2025Causes 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.

Secondary

MeasureTime frameDescription
All-cause MortalityAs of December 31, 2025Deaths caused by all reasons, including but not limited to those related to liver disease

Contacts

Primary ContactRui Huang, Dr.
strangehead@163.com86 10 66583771

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026