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Completed

NCT Number: NCT06399081

Construction of a Predictive Model of Gangrenous Cholecystitis Based on Machine Learning

Gangrenous cholecystitis is the most common complication of acute cholecystitis.

There is no research using machine learning models to construct predictive diagnostic models for gangrenous cholecystitis.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

About this study

This study reviewed the clinical data of 2023 cholecystectomy patients admitted to our center between January 1, 2015, and May 31, 2015, it includes demographic, clinical features, laboratory and imaging indexes, and constructs five commonly used Decision Tree, SVM, Random Forest, XGBoost, AdaBoost models, feature subsets are selected by Recursive Feature Elimination with Cross-Validation and the importance of variables in each model, model performance is evaluated by Balanced accuracy, Recall, Precision, F1score, and the Precision-Recall(PR) curve, and the final results are verified by independent external validation sets.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with acute cholecystitis or acute exacerbation of chronic cholecystitis in our hospital and receiving complete clinical treatment in our hospital;
  • performing cholecystectomy;
  • having complete and searchable clinical data, such as patient's age, surgical records, and hospitalization days.

Exclusion criteria

  • previous diagnosis of chronic cholecystitis, this time for elective surgical treatment;
  • previous diagnosis of acute cholecystitis, ultrasound-guided cholecystectomy after elective laparoscopic cholecystectomy;
  • concomitant with other acute biliary and pancreatic system-related diseases, such as obstructive jaundice caused by choledochal stones, acute cholangitis, acute pancreatitis, etc.;
  • exclude patients who combined with other surgery patients such as choledochotomy and lithotripsy, choledochoscopic exploration and lithotripsy, bile-intestinal anastomosis, appendectomy, etc;
  • those with incomplete data

Treatment and study plan

Observational

Other

Observational

Primary outcomes

  1. pathological diagnosis of patients with cholecystectomy

    Time frame: 30 days

    Check the patient's pathological report and whether the pathological description contains phenomena such as full layer ischemic necrosis and ulceration of the gallbladder wall. Diagnose as gangrenous cholecystitis or non-gangrenous cholecystitis.

  2. The predictive performance of diagnostic prediction models

    Time frame: through study completion, an average of 4 months

    The predictive diagnosis was obtained by the model and each predictive variable, and the metric (Accuracy, Recall, Precision, F1score) of the model was obtained by comparing with the actual pathological diagnosis.

Secondary outcomes

  1. WBC value (10*9/L)

    Time frame: through study completion, an average of 4 months

    Correlation between WBC and patients with gangrenous cholecystitis and non-gangrenous cholecystitis

  2. Alanine transaminase value (ALT, U/L)

    Time frame: through study completion, an average of 4 months

    Correlation between liver function and patients with gangrenous cholecystitis and non-gangrenous cholecystitis

  3. D-dimer value

    Time frame: through study completion, an average of 4 months

    Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis

  4. Fibrinogen value (g/L)

    Time frame: through study completion, an average of 4 months

    Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis

  5. BMI (Kg/m2)

    Time frame: through study completion, an average of 4 months

    Correlation between obesity level and patients with gangrenous cholecystitis and non-gangrenous cholecystitis

  6. Gallbladder wallness (cm)

    Time frame: through study completion, an average of 4 months

    Correlation between Gallbladder wallness and patients with gangrenous cholecystitis and non-gangrenous cholecystitis

Sponsors and collaborators

Lead sponsor

Dalian Medical University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

A Real-world Study of Predictive Models of Gangrenous Cholecystitis Based on Machine Learning

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
May 3, 2024

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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