Gangrenous CholecystitisNCT06399081
Construction of a Predictive Model of Gangrenous Cholecystitis Based on Machine Learning
An observational study of Gangrenous Cholecystitis, run by Dalian Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gangrenous Cholecystitis
- What is being tested?
- Observational
- How many people
- 1,006 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 2 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023
About this study
Official title: 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.
Read the 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.
- Conditions
- Gangrenous Cholecystitis
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Gangrenous cholecystitis | Defined based on intraoperative findings or pathological diagnosis Receives: Other: Observational | |
| Non-gangrenous cholecystitis | Non-gangrenous cholecystitis, such as chronic cholecystitis, acute cholecystitis, acute attack of chronic cholecystitis Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 4 months
Secondary outcomes (6)
WBC value (10*9/L)
Correlation between WBC and patients with gangrenous cholecystitis and non-gangrenous cholecystitis
Measured: 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
Measured: through study completion, an average of 4 months
D-dimer value
Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis
Measured: through study completion, an average of 4 months
Fibrinogen value (g/L)
Correlation between coagulopathy and patients with gangrenous cholecystitis and non-gangrenous cholecystitis
Measured: through study completion, an average of 4 months
BMI (Kg/m2)
Correlation between obesity level and patients with gangrenous cholecystitis and non-gangrenous cholecystitis
Measured: through study completion, an average of 4 months
Gallbladder wallness (cm)
Correlation between Gallbladder wallness and patients with gangrenous cholecystitis and non-gangrenous cholecystitis
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Dec 2023
- Primary completion1 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gangrenous CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Ying Ma, Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399081
- Sponsor's protocol ID
- KY2024-006-02
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 24635779Yacoub 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.
PubMed 20631896Borzellino 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.
PubMed 17704863
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Predictive Models of Gangrenous Cholecystitis Based on Machine Learning
- ClinicalTrials.gov ID
- NCT06399081
- Acronym / sponsor ID
- KY2024-006-02
- Conditions
- Gangrenous Cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gangrenous cholecystitis | – | Other: ObservationalDefined based on intraoperative findings or pathological diagnosis |
| Non-gangrenous cholecystitis | – | Other: ObservationalNon-gangrenous cholecystitis, such as chronic cholecystitis, acute cholecystitis, acute attack of chronic cholecystitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Gangrenous cholecystitis, Non-gangrenous cholecystitis |
Primary outcome
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.
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.
6 secondary outcomes
WBC value (10*9/L)
Time frame: through study completion, an average of 4 months
Alanine transaminase value (ALT, U/L)
Time frame: through study completion, an average of 4 months
D-dimer value
Time frame: through study completion, an average of 4 months
Fibrinogen value (g/L)
Time frame: through study completion, an average of 4 months
BMI (Kg/m2)
Time frame: through study completion, an average of 4 months
Gallbladder wallness (cm)
Time frame: through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 24635779Wu 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.
- Background: PubMed 20631896Yacoub 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.
- Background: PubMed 17704863Borzellino 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.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gangrenous Cholecystitis, run by Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological diagnosis of patients with cholecystectomy (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06399081, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.