Clinical trial NCT06399081: Construction of a Predictive Model of Gangrenous Cholecystitis Based on Machine Learning
Official title: A Real-world Study of Predictive Models of Gangrenous Cholecystitis Based on Machine Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gangrenous Cholecystitis
Lead sponsor: Dalian Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-05-03
Enrollment: 1006
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pathological diagnosis of patients with cholecystectomy
timeFrame: 30 days
measure: The predictive performance of diagnostic prediction models
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: WBC value (10*9/L)
timeFrame: through study completion, an average of 4 months
measure: Alanine transaminase value (ALT, U/L)
timeFrame: through study completion, an average of 4 months
measure: D-dimer value
timeFrame: through study completion, an average of 4 months
measure: Fibrinogen value (g/L)
timeFrame: through study completion, an average of 4 months
measure: BMI (Kg/m2)
timeFrame: through study completion, an average of 4 months
measure: Gallbladder wallness (cm)
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
Study officials:
References:
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.
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.
citation: 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.