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

NCT06531200 | Not Yet Recruiting

• 1 other identifier: 2023PHB214-001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhosis, Liver; Sarcopenia

Keywords

deep learning; prognosis; sarcopenia; myosteatosis

Outcome Measures

Primary Outcomes (1)

• Liver-related mortality

  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.

  As of December 31, 2025

Secondary Outcomes (1)

• All-cause Mortality

  As of December 31, 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes adults diagnosed with liver cirrhosis based on clinical criteria, liver biopsy confirming cirrhosis, or specific laboratory abnormalities (e.g., low platelet count, low serum albumin, high INR, or elevated APRI). Additionally, high-quality L3-level CT images must be available for each patient. Patients are excluded if they have incomplete data, a diagnosis or suspicion of malignancy, severe chronic diseases (such as kidney, respiratory, or cardiovascular conditions), neurological or muscular degenerative diseases, metabolic disorders (like thyroid diseases or tuberculosis), malabsorption conditions, or if they are undergoing treatment with glucocorticoids or immunosuppressants. Pregnant or lactating women are also excluded from the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (29)

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MeSH Terms

Conditions

Liver Cirrhosis; Sarcopenia

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Rui Huang, Dr.

  Rui Huang, Dr. PekignUnviersity People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Huang, Dr.

CONTACT

86 10 66583771; strangehead@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: September 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08