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

A Real-world Study of Predictive Models 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.

Study Overview

• Status: Completed
• Conditions: Gangrenous Cholecystitis
• Intervention / Treatment: Other: Observational

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 1006

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116023
      • The Second Hospital of Dalian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients admitted to the Second Hospital of Dalian Medical University who were diagnosed with cholecystitis through ICD-9 code recognition and underwent cholecystectomy from January 2015 to May 2023

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gangrenous cholecystitis; Defined based on intraoperative findings or pathological diagnosis	Other: Observational; Observational
Non-gangrenous cholecystitis; Non-gangrenous cholecystitis, such as chronic cholecystitis, acute cholecystitis, acute attack of chronic cholecystitis	Other: Observational; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
D-dimer value	Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
Fibrinogen value (g/L)	Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
BMI (Kg/m2)	Correlation between obesity level and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months
Gallbladder wallness (cm)	Correlation between Gallbladder wallness and patients with gangrenous cholecystitis and non-gangrenous cholecystitis	through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Dalian Medical University
• Collaborators: National Natural Science Foundation of China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 2, 2024

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Estimated): May 3, 2024

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Necrosis; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Gangrene
• Other Study ID Numbers: KY2024-006-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data where our results derived from were from the Second Hospital of Dalian Medical University. The original data were not publicly available and could only be shared with the permission of the Ethics Committee of the Second Hospital of Dalian Medical University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No