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

Gangrenous Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399081
• Other study ID #: KY2024-006-02
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: March 2, 2024

Study information

• Verified date: May 2024
• Source: Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1006
• Est. completion date: March 2, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Gangrene
• Gangrenous Cholecystitis

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Dalian Medical University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (3)

Borzellino G, Sauerland S, Minicozzi AM, Verlato G, Di Pietrantonj C, de Manzoni G, Cordiano C. Laparoscopic cholecystectomy for severe acute cholecystitis. A meta-analysis of results. Surg Endosc. 2008 Jan;22(1):8-15. doi: 10.1007/s00464-007-9511-6. Epub 2007 Aug 18. — View Citation

Wu B, Buddensick TJ, Ferdosi H, Narducci DM, Sautter A, Setiawan L, Shaukat H, Siddique M, Sulkowski GN, Kamangar F, Kowdley GC, Cunningham SC. Predicting gangrenous cholecystitis. HPB (Oxford). 2014 Sep;16(9):801-6. doi: 10.1111/hpb.12226. Epub 2014 Mar 17. — View Citation

Yacoub WN, Petrosyan M, Sehgal I, Ma Y, Chandrasoma P, Mason RJ. Prediction of patients with acute cholecystitis requiring emergent cholecystectomy: a simple score. Gastroenterol Res Pract. 2010;2010:901739. doi: 10.1155/2010/901739. Epub 2010 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological diagnosis of patients with cholecystectomy	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.	30 days
Primary	The predictive performance of diagnostic prediction models	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.	through study completion, an average of 4 months
Secondary	WBC value (10*9/L)	Correlation between WBC and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
Secondary	Alanine transaminase value (ALT, U/L)	Correlation between liver function and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
Secondary	D-dimer value	Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
Secondary	Fibrinogen value (g/L)	Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
Secondary	BMI (Kg/m2)	Correlation between obesity level and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
Secondary	Gallbladder wallness (cm)	Correlation between Gallbladder wallness and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months