Acute PancreatitisNCT04735055
Artificial Intelligence Prediction for the Severity of Acute Pancreatitis
An observational study of Acute Pancreatitis and Artificial Intelligence, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The incidence of acute pancreatitis (AP) is increasing nowadays. The diagnosis of AP is defined according to Atlanta criteria with the presence of two of the following 3 findings; a) characteristic abdominal pain b) amylase and lipase values ≥3 times c) AP diagnosis in ultrasonography (USG), magnetic resonance imaging… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Pancreatitis, Artificial Intelligence, Outcome, Fatal
- How many people
- 1,334 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2020to 30 Sep 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute pancreatitis diagnosis according to the Atlanta criteria
Who may be able to join
- Patients with acute pancreatitis diagnosis who admitted to ER within 24 hours after the beginning of abdominal pain
Who cannot join
- Patients who sign a treatment rejection form immediately after admission to the hospital and leave the hospital
- Patients with uncompleted data
- Psychiatric patients
- Patients with very poor general conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University, Gastroenterology Clinic
Istanbul, 34093
About this study
Official title: Artificial Intelligence Application in Predicting Disease Severity in Acute Pancreatitis
The incidence of acute pancreatitis (AP) is increasing nowadays. The diagnosis of AP is defined according to Atlanta criteria with the presence of two of the following 3 findings; a) characteristic abdominal pain b) amylase and lipase values ≥3 times c) AP diagnosis in ultrasonography (USG), magnetic resonance imaging (MRI), or computerized tomography (CT) imaging. While 80% of the disease has a mild course, 20% is severe and requires intensive care treatment. Mortality varies between 10-25% in severe (severe) AP, while it is 1-3% in mild AP.
Scoring systems with clinical, laboratory, and radiological findings are used to evaluate the severity of the disease. Advanced age (>70yo), obesity (as body mass index (BMI, as kg/m2), cigarette and alcohol usage, blood urea nitrogen (BUN) ≥20 mg/dl, increased creatinine, C reactive protein level (CRP) >120mg/dl, decreased or increased Hct levels, ≥8 Balthazar score on abdominal CT implies serious AP. According to the revised Atlanta criteria, three types of severity are present in AP. Mild (no organ failure and no local complications), moderate (local complications such as pseudocyst, abscess, necrosis, vascular thrombosis) and/or transient systemic complications (less than 48h) and severe (long-lasting systemic complications (>48h); organ insufficiencies such as lung, heart, gastrointestinal and renal). Although Atlanta scoring is considered very popular today, it still seems to be in need of revision due to some deficiencies in the subjects of infected necrosis, non-pancreatic infection and non-pancreatic necrosis, and the dynamic nature of organ failure. Even though the presence of 30 severity scoring systems (the most accepted one is the APACHE 2 score among them), none of them can definitely predict which patient will have very severe disease and which patient will have a mild course has not been discovered yet.
Today, artificial intelligence (machine learning) applications are used in many subjects in medicine (such as diagnosis, surgeries, drug development, personalized treatments, gene editing skills). Studies on machine learning in determining the violence in AP have started to appear in the literature. The purpose of this study is to investigate whether the artificial intelligence (AI) application has a role in determining the disease severity in AP.
Read the detailed description
In a retrospective way, 1550 patients who were followed up at the Gastroenterology Clinic of Bezmialem Foundation University between October 2010 and February 2020 period and who were diagnosed with AP according to Atlanta criteria were screened. After the removal of 216 patients with missing data, 1334 patients were included in the study for evaluation.
- Patient demographic information; [age (yo), gender (male/female), cigarette/alcohol usage (as yes or no)], clinical information; [height (centimeters), weight (kilograms), BMI (as kg/m2), presence of diabetes mellitus and hypertension (yes or no)], etiology of AP such as gallstones, alcohol, etc., and laboratory tests those taken within the first 24 hours of the admission; [CRP level (mg/dl, normally: 0-5), BUN level (mg/dl, normally; 9,8 - 20,1), creatinine level (mg/dl, normally; 0,57 - 1,11), number of leukocytes (normally 4.5 to 11.0 ×109/L) and hematocrit level (%, normally: 35,5-48%)], as well as Balthazar tomographic scoring [0: normal, 1: an increase in pancreatic size, 2: inflammatory changes in pancreatic tissue and peripancreatic fatty tissue, 3: irregularly bordered, single fluid collection, 4: irregularly bordered 2 or more fluid collections, 5 to 10 different degrees of necrosis)], will be recorded in the excel file.
- Revised Atlanta scoring will also be recorded within a week period of hospital admission as mild, moderate, and severe scores. Infected pancreatic necrosis and sepsis that developed during the course of acute pancreatitis will be accepted as severe acute pancreatitis due to the inadequacy of some issues in Atlanta scoring. The severity of the disease will be evaluated according to the Atlanta scores. And the results of the artificial intelligence study will be matched according to the results of Atlanta scoring.
- Complications are classified as 0; none, 2; local complications: pseudocyst, abscess, necrosis, thrombosis, and mesenteric panniculitis, 3; systemic complications: lung, kidney, gastrointestinal and cardiovascular complications, 4; mixed serious complications/co-morbidity situations, 5: infectious and septic complications.
- Additionally, invasive procedure requirements such as endoscopic ultrasonography (EUS), endoscopic retrograde cholangiopancreatography (ERCP) (as yes or no), length of hospital stay (less than 10 days or more than 11 days), intensive care unit requirement (present or not), number of future AP attacks (in duration after a month of hospital admission, as of one attack or more than one attack), and survival (death, alive) will also be recorded.
Machine Learning Algorithm is used: Gradient Boosted Ensemble Trees Trees. ("Greedy Function Approximation: A Gradient Boosting Machine" by Jerome H. Friedman (1999)). The dataset has been partitioned with a 90%-10% ratio. 10% is for validation and 90% is for AI machine learning. 90% machine learning part has also been divided into two parts as 70% for AI Learning and 30% for testing the learning. For this purpose, 5-fold stratified sampling has been used
Artificial Intelligence Methods of the Study
Features Used for AI Machine Learning:
- Gender: M/F
- Age: Continuous Value
- Height (cm): Continuous Value
- Weight (Kg): Continuous Value
- BMI Groups: Group 1: ≤ 25 kg/m2; Group 2; 25-30 kg/m2; Group 3: >30,1 kg/m2
- Cigarette: 0; No, 1; Yes
- Alcohol: 0; No, 1; Yes
- Diabetes mellitus: 0; No, 1; Yes
- Hypertension: 0; No, 1; Yes
- Etiology: 1; biliary, 2; Alcohol, 3; hypertriglyceridemia, 4; hypercalcemia, 5; drug, 6; congenital, 7; cryptogenic, 8; endoscopic retrograde cholangiography (ERCP), 9; oddy sphincter dysfunction (OSD), 10; malignity, 11; intra papillary mucinous neoplasia (IPMN), 12: primary sclerosing cholangiography (PSC) 13: autoimmune, 14: multiple etiology
- Leucocyte number (WBC): N; 4,5-11x100
- Hematocrit (Hct): N; %35,5-48
- C reactive protein (CRP): N: 0-5 mg/dl
- Blood urea nitrogen (BUN): N: 9,8-20,1 mg/dl
- Creatinine (KREA): N: 0,57-1,11 mg/dl
- Baltazar Scoring (BLTZR): 0; Normal P, 1; Increase in pancreatic size, 2; Inflammatory changes in pancreatic tissue and peripancreatic fatty tissue, 3; Irregularly bordered, single fluid collection, 4, Irregularly bordered 2 or more fluid collections, with various degrees of necrosis (ranging between 5 and 10)
In Artificial Intelligence, Decision Tree Models are widely used for supervised machine learning. They may depend on the Gini index, gain ratio/entropy, chi-square, regression, and so on. In AI they are preferred because they generate understandable rules for humans unlike other machine learning algorithms such as Artificial Neural Networks and Support Vector Machines. On the other hand, they are considered to be weak learners. That means they are highly affected by noise and outliers existing in the data set. In order to go around this handicap, models like Random Forest, Ensemble Trees, Gradient Boosting have been developed.
Random forest and Ensemble trees generate rules by applying a certain decision tree algorithm to the portions of the data set vertically and horizontally. This technique dramatically reduces the error occurring in learning. After learning processes are completed, they combine weak decision trees into a strong and bigger decision tree model. Ensemble learning models achieve better learning by minimizing the average value of the loss function on the training set via a F ̂(x) approximation. The idea is to apply a steepest descent step to the minimization problem in a greedy fashion.
In this study, the gradient boost tree model which was proposed by Friedman has been used for machine learning. This model chooses a separate optimal value for each of the tree's parts rather than a single one for the whole tree. This approach can be used to minimize any differentiable loss L(y, F) in conjunction with forwarding stage-wise additive modeling. It is reported that the gradient boosting tree model outperforms random forest and regular ensemble trees in many cases.
The goal of the algorithm is to find an approximation F_m (x_i) which minimizes the expected L(y,F(x)) loss function.
The algorithm may be summarized as follows:
Inputs:
A training data set: {(x_i,y_i )} i=1 to n with n dimension and a class variable A differentiable loss function: L(y,F(x)) The number of iterations: M.
Output:
F_m (x_i)
Algorithm:
Initialize the model with a constant value:
F_0 (x)=arg min∑_(i=1)^n▒〖L(y_i,γ)〗
For m = 1 to M:
Compute pseudo-residuals rim r_im=-[(∂L(y_(i,) F(x_i )))/(∂F(x_i))]
Train a base learner to pseudo-residuals, using the training set:
{(x_i,y_i )} i=1 to n Compute multiplier γ γ=arg min∑_(i=1)^n▒〖L(y_i,F_(m-1) (x_i )+γh_m (x_i ))〗
Update the model:
〖F_m (x_i)=F〗_(m-1) (x_i )+γ_m h_m (x_i ) Output F_m (x_i)
In the analysis, Synthetic Minority Oversampling Technique (SMOTE) [5] has been used in order to avoid the disadvantage of class variable imbalance. SMOTE is a data augmentation technique to increase data. In some cases, the class variable may not have an equal amount of values from all cases. For example, there may be much more survived patients than those who lost their lives. In this kind of situation, data are augmented. There was an imbalance in the class variables in the data set of this study. So, SMOTE has been applied to increase the minority classes for training.
The dataset has been partitioned with a 90%-10% ratio. 10% is for validation and 90% is for AI machine learning. 90% machine learning part has also been divided into two parts as 70% for AI Learning and 30% for testing the learning. For this purpose, 5-fold stratified sampling has been used. KNIME analytic platform has been used for the AI machine learning.
- Conditions
- Acute Pancreatitis, Artificial Intelligence, Outcome, Fatal
- Keywords
- Acute pancreatitis, Artificial intelligence,
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Artificial intelligence (AI) machine learning group | 90% machine learning part has also been divided into 2 parts as 70% for AI learning and 30% for testing the learning. 70% of the acute pancreatitis patients (approximately 840 pts) will form the model training group of the study. 30% of the acute pancreatitis patients (approximately 360 pts) will form the testing group of the study. Since cross-validation will also be applied to the model here, the data will also change within itself, and also the distribution will be optimized to increase the predictive power. | |
| Validation group | 10% of the acute pancreatitis patients (approximately 134) will form the validation group of the study. Since cross-validation will also be applied to the model here, the data will also change within itself, and also the distribution will be optimized to increase the predictive power. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurately estimation of the severity of the disease by machine learning method
Severity is described as mild, moderate, and severe acute pancreatitis according to the revised Atlanta criteria.
Measured: Within a week.
Secondary outcomes (5)
Invasive procedure requirement
Need for EUS or ERCP during hospital stay for evaluation of the reasons such as distal choledochal obstruction by stone, pseudocyst or necrosis developments (As yes or no)
Measured: Within a week
Intensive care unit requirement
Transferring the patient to the ICU where life support is needed in order to survive if patients have dyspnea (if respiratory rate is more than 25/minute), hypotension (less than 90/60 mmHg), if patient have gastrointestinal bleeding (more than 2 lt. in a day), if the patient's BUN level is higher than 20 mg's and progressively increases (as yes or no)
Measured: Within a week
Survival status
Death: if patient is alive (yes) if dies (no)
Measured: Within a week
Length of hospital stay
Durations lasted in hospital as a day (as less than 10 days or more than 10 days)
Measured: Within a month
Number of AP attacks
Admission to the hospital again with the AP attack.
Measured: After a month of hospital admission as one attack or more than one attack
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start3 Sep 2020
- Primary completion23 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Ali Tüzün İnce, Bezmialem Vakif University
- Investigators
- Gökhan Silahtaroğlu, Prof., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735055
- Sponsor's protocol ID
- MLKkrm986%
- Status last verified
- Apr 2021
- First submitted
- 30 Sep 2020
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Fei Y, Gao K, Li WQ. Artificial neural network algorithm model as powerful tool to predict acute lung injury following to severe acute pancreatitis. Pancreatology. 2018 Dec;18(8):892-899. doi: 10.1016/j.pan.2018.09.007. Epub 2018 Sep 26.
PubMed 30268673van den Heever M, Mittal A, Haydock M, Windsor J. The use of intelligent database systems in acute pancreatitis--a systematic review. Pancreatology. 2014 Jan-Feb;14(1):9-16. doi: 10.1016/j.pan.2013.11.010. Epub 2013 Dec 4.
PubMed 24555973Yoldas O, Koc M, Karakose N, Kilic M, Tez M. Prediction of clinical outcomes using artificial neural networks for patients with acute biliary pancreatitis. Pancreas. 2008 Jan;36(1):90-2. doi: 10.1097/MPA.0b013e31812e964b. No abstract available.
PubMed 18192888Pearce CB, Gunn SR, Ahmed A, Johnson CD. Machine learning can improve prediction of severity in acute pancreatitis using admission values of APACHE II score and C-reactive protein. Pancreatology. 2006;6(1-2):123-31. doi: 10.1159/000090032. Epub 2005 Dec 1.
PubMed 16327290Andersson B, Andersson R, Ohlsson M, Nilsson J. Prediction of severe acute pancreatitis at admission to hospital using artificial neural networks. Pancreatology. 2011;11(3):328-35. doi: 10.1159/000327903. Epub 2011 Jul 9.
PubMed 21757970Qiu Q, Nian YJ, Guo Y, Tang L, Lu N, Wen LZ, Wang B, Chen DF, Liu KJ. Development and validation of three machine-learning models for predicting multiple organ failure in moderately severe and severe acute pancreatitis. BMC Gastroenterol. 2019 Jul 4;19(1):118. doi: 10.1186/s12876-019-1016-y.
PubMed 31272385Greedy function approximation: A gradient boostingmachine.
Clustering, A. (2009). Clustering Categorical Data Using Hierarchies. Engineering and Technology, 1(2), 334-339.
Silahtaroğlu, G. (2009). An Attribute-Centre Based Decision Tree Classification Algorithm. Engineering and Technology, 302-306.
Bentéjac, C., Csörgő, A., & Martínez-Muñoz, G. (2021). A comparative analysis of gradient boosting algorithms. Artificial Intelligence Review, 54(3). https://doi.org/10.1007/s10462-020-09896-5.
Bentéjac, C., Csörgő, A., & Martínez-Muñoz, G. (2021). A comparative analysis of gradient boosting algorithms. Artificial Intelligence Review, 54(3). https://doi.org/10.1007/s10462-020-09896-5
Berthold, M. R., Cebron, N., Dill, F., Gabriel, T. R., Kötter, T., Meinl, T., … Wiswedel, B. (2009). KNIME - the Konstanz information miner. ACM SIGKDD Explorations Newsletter. https://doi.org/10.1145/1656274.1656280
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Application in Predicting Disease Severity in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT04735055
- Acronym / sponsor ID
- MLKkrm986%
- Conditions
- Acute Pancreatitis, Artificial Intelligence, Outcome, Fatal
- Keywords
- Acute pancreatitis, Artificial intelligence,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,334 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 2 Feb 2021 (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.
The incidence of acute pancreatitis (AP) is increasing nowadays. The diagnosis of AP is defined according to Atlanta criteria with the presence of two of the following 3 findings; a) characteristic abdominal pain b) amylase and lipase values ≥3 times c) AP diagnosis in ultrasonography (USG), magnetic resonance imaging (MRI), or computerized tomography (CT) imaging. While 80% of the disease has a mild course, 20% is severe and requires intensive care treatment. Mortality varies between 10-25% in severe (severe) AP, while it is 1-3% in mild AP.
Scoring systems with clinical, laboratory, and radiological findings are used to evaluate the severity of the disease. Advanced age (>70yo), obesity (as body mass index (BMI, as kg/m2), cigarette and alcohol usage, blood urea nitrogen (BUN) ≥20 mg/dl, increased creatinine, C reactive protein level (CRP) >120mg/dl, decreased or increased Hct levels, ≥8 Balthazar score on abdominal CT implies serious AP. According to the revised Atlanta criteria, three types of severity are present in AP. Mild (no organ failure and no local complications), moderate (local complications such as pseudocyst, abscess, necrosis, vascular thrombosis) and/or transient systemic complications (less than 48h) and severe (long-lasting systemic complications (>48h); organ insufficiencies such as lung, heart, gastrointestinal and renal). Although Atlanta scoring is considered very popular today, it still seems to be in need of revision due to some deficiencies in the subjects of infected necrosis, non-pancreatic infection and non-pancreatic necrosis, and the dynamic nature of organ failure. Even though the presence of 30 severity scoring systems (the most accepted one is the APACHE 2 score among them), none of them can definitely predict which patient will have very severe disease and which patient will have a mild course has not been discovered yet.
Today, artificial intelligence (machine learning) applications are used in many subjects in medicine (such as diagnosis, surgeries, drug development, personalized treatments, gene editing skills). Studies on machine learning in determining the violence in AP have started to appear in the literature. The purpose of this study is to investigate whether the artificial intelligence (AI) application has a role in determining the disease severity in AP.
Detailed description
In a retrospective way, 1550 patients who were followed up at the Gastroenterology Clinic of Bezmialem Foundation University between October 2010 and February 2020 period and who were diagnosed with AP according to Atlanta criteria were screened. After the removal of 216 patients with missing data, 1334 patients were included in the study for evaluation.
- Patient demographic information; [age (yo), gender (male/female), cigarette/alcohol usage (as yes or no)], clinical information; [height (centimeters), weight (kilograms), BMI (as kg/m2), presence of diabetes mellitus and hypertension (yes or no)], etiology of AP such as gallstones, alcohol, etc., and laboratory tests those taken within the first 24 hours of the admission; [CRP level (mg/dl, normally: 0-5), BUN level (mg/dl, normally; 9,8 - 20,1), creatinine level (mg/dl, normally; 0,57 - 1,11), number of leukocytes (normally 4.5 to 11.0 ×109/L) and hematocrit level (%, normally: 35,5-48%)], as well as Balthazar tomographic scoring [0: normal, 1: an increase in pancreatic size, 2: inflammatory changes in pancreatic tissue and peripancreatic fatty tissue, 3: irregularly bordered, single fluid collection, 4: irregularly bordered 2 or more fluid collections, 5 to 10 different degrees of necrosis)], will be recorded in the excel file.
- Revised Atlanta scoring will also be recorded within a week period of hospital admission as mild, moderate, and severe scores. Infected pancreatic necrosis and sepsis that developed during the course of acute pancreatitis will be accepted as severe acute pancreatitis due to the inadequacy of some issues in Atlanta scoring. The severity of the disease will be evaluated according to the Atlanta scores. And the results of the artificial intelligence study will be matched according to the results of Atlanta scoring.
- Complications are classified as 0; none, 2; local complications: pseudocyst, abscess, necrosis, thrombosis, and mesenteric panniculitis, 3; systemic complications: lung, kidney, gastrointestinal and cardiovascular complications, 4; mixed serious complications/co-morbidity situations, 5: infectious and septic complications.
- Additionally, invasive procedure requirements such as endoscopic ultrasonography (EUS), endoscopic retrograde cholangiopancreatography (ERCP) (as yes or no), length of hospital stay (less than 10 days or more than 11 days), intensive care unit requirement (present or not), number of future AP attacks (in duration after a month of hospital admission, as of one attack or more than one attack), and survival (death, alive) will also be recorded.
Machine Learning Algorithm is used: Gradient Boosted Ensemble Trees Trees. ("Greedy Function Approximation: A Gradient Boosting Machine" by Jerome H. Friedman (1999)). The dataset has been partitioned with a 90%-10% ratio. 10% is for validation and 90% is for AI machine learning. 90% machine learning part has also been divided into two parts as 70% for AI Learning and 30% for testing the learning. For this purpose, 5-fold stratified sampling has been used
Artificial Intelligence Methods of the Study
Features Used for AI Machine Learning:
- Gender: M/F
- Age: Continuous Value
- Height (cm): Continuous Value
- Weight (Kg): Continuous Value
- BMI Groups: Group 1: ≤ 25 kg/m2; Group 2; 25-30 kg/m2; Group 3: >30,1 kg/m2
- Cigarette: 0; No, 1; Yes
- Alcohol: 0; No, 1; Yes
- Diabetes mellitus: 0; No, 1; Yes
- Hypertension: 0; No, 1; Yes
- Etiology: 1; biliary, 2; Alcohol, 3; hypertriglyceridemia, 4; hypercalcemia, 5; drug, 6; congenital, 7; cryptogenic, 8; endoscopic retrograde cholangiography (ERCP), 9; oddy sphincter dysfunction (OSD), 10; malignity, 11; intra papillary mucinous neoplasia (IPMN), 12: primary sclerosing cholangiography (PSC) 13: autoimmune, 14: multiple etiology
- Leucocyte number (WBC): N; 4,5-11x100
- Hematocrit (Hct): N; %35,5-48
- C reactive protein (CRP): N: 0-5 mg/dl
- Blood urea nitrogen (BUN): N: 9,8-20,1 mg/dl
- Creatinine (KREA): N: 0,57-1,11 mg/dl
- Baltazar Scoring (BLTZR): 0; Normal P, 1; Increase in pancreatic size, 2; Inflammatory changes in pancreatic tissue and peripancreatic fatty tissue, 3; Irregularly bordered, single fluid collection, 4, Irregularly bordered 2 or more fluid collections, with various degrees of necrosis (ranging between 5 and 10)
In Artificial Intelligence, Decision Tree Models are widely used for supervised machine learning. They may depend on the Gini index, gain ratio/entropy, chi-square, regression, and so on. In AI they are preferred because they generate understandable rules for humans unlike other machine learning algorithms such as Artificial Neural Networks and Support Vector Machines. On the other hand, they are considered to be weak learners. That means they are highly affected by noise and outliers existing in the data set. In order to go around this handicap, models like Random Forest, Ensemble Trees, Gradient Boosting have been developed.
Random forest and Ensemble trees generate rules by applying a certain decision tree algorithm to the portions of the data set vertically and horizontally. This technique dramatically reduces the error occurring in learning. After learning processes are completed, they combine weak decision trees into a strong and bigger decision tree model. Ensemble learning models achieve better learning by minimizing the average value of the loss function on the training set via a F ̂(x) approximation. The idea is to apply a steepest descent step to the minimization problem in a greedy fashion.
In this study, the gradient boost tree model which was proposed by Friedman has been used for machine learning. This model chooses a separate optimal value for each of the tree's parts rather than a single one for the whole tree. This approach can be used to minimize any differentiable loss L(y, F) in conjunction with forwarding stage-wise additive modeling. It is reported that the gradient boosting tree model outperforms random forest and regular ensemble trees in many cases.
The goal of the algorithm is to find an approximation F_m (x_i) which minimizes the expected L(y,F(x)) loss function.
The algorithm may be summarized as follows:
Inputs:
A training data set: {(x_i,y_i )} i=1 to n with n dimension and a class variable A differentiable loss function: L(y,F(x)) The number of iterations: M.
Output:
F_m (x_i)
Algorithm:
Initialize the model with a constant value:
F_0 (x)=arg min∑_(i=1)^n▒〖L(y_i,γ)〗
For m = 1 to M:
Compute pseudo-residuals rim r_im=-[(∂L(y_(i,) F(x_i )))/(∂F(x_i))]
Train a base learner to pseudo-residuals, using the training set:
{(x_i,y_i )} i=1 to n Compute multiplier γ γ=arg min∑_(i=1)^n▒〖L(y_i,F_(m-1) (x_i )+γh_m (x_i ))〗
Update the model:
〖F_m (x_i)=F〗_(m-1) (x_i )+γ_m h_m (x_i ) Output F_m (x_i)
In the analysis, Synthetic Minority Oversampling Technique (SMOTE) [5] has been used in order to avoid the disadvantage of class variable imbalance. SMOTE is a data augmentation technique to increase data. In some cases, the class variable may not have an equal amount of values from all cases. For example, there may be much more survived patients than those who lost their lives. In this kind of situation, data are augmented. There was an imbalance in the class variables in the data set of this study. So, SMOTE has been applied to increase the minority classes for training.
The dataset has been partitioned with a 90%-10% ratio. 10% is for validation and 90% is for AI machine learning. 90% machine learning part has also been divided into two parts as 70% for AI Learning and 30% for testing the learning. For this purpose, 5-fold stratified sampling has been used. KNIME analytic platform has been used for the AI machine learning.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial intelligence (AI) machine learning group | – | –90% machine learning part has also been divided into 2 parts as 70% for AI learning and 30% for testing the learning. 70% of the acute pancreatitis patients (approximately 840 pts) will form the model training group of the study. 30% of the acute pancreatitis patients (approximately 360 pts) will form the testing group of the study. Since cross-validation will also be applied to the model here, the data will also change within itself, and also the distribution will be optimized to increase the predictive power. |
| Validation group | – | –10% of the acute pancreatitis patients (approximately 134) will form the validation group of the study. Since cross-validation will also be applied to the model here, the data will also change within itself, and also the distribution will be optimized to increase the predictive power. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute pancreatitis diagnosis according to the Atlanta criteria
Key inclusion criteria (1 listed)
- Patients with acute pancreatitis diagnosis who admitted to ER within 24 hours after the beginning of abdominal pain
Key exclusion criteria (4 listed)
- Patients who sign a treatment rejection form immediately after admission to the hospital and leave the hospital
- Patients with uncompleted data
- Psychiatric patients
- Patients with very poor general conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accurately estimation of the severity of the disease by machine learning method
Time frame: Within a week.
Severity is described as mild, moderate, and severe acute pancreatitis according to the revised Atlanta criteria.
5 secondary outcomes
Invasive procedure requirement
Time frame: Within a week
Intensive care unit requirement
Time frame: Within a week
Survival status
Time frame: Within a week
Length of hospital stay
Time frame: Within a month
Number of AP attacks
Time frame: After a month of hospital admission as one attack or more than one attack
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 5 May 2021.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Background: PubMed 30268673Fei Y, Gao K, Li WQ. Artificial neural network algorithm model as powerful tool to predict acute lung injury following to severe acute pancreatitis. Pancreatology. 2018 Dec;18(8):892-899. doi: 10.1016/j.pan.2018.09.007. Epub 2018 Sep 26.
- Background: PubMed 24555973van den Heever M, Mittal A, Haydock M, Windsor J. The use of intelligent database systems in acute pancreatitis--a systematic review. Pancreatology. 2014 Jan-Feb;14(1):9-16. doi: 10.1016/j.pan.2013.11.010. Epub 2013 Dec 4.
- Background: PubMed 18192888Yoldas O, Koc M, Karakose N, Kilic M, Tez M. Prediction of clinical outcomes using artificial neural networks for patients with acute biliary pancreatitis. Pancreas. 2008 Jan;36(1):90-2. doi: 10.1097/MPA.0b013e31812e964b. No abstract available.
- Background: PubMed 16327290Pearce CB, Gunn SR, Ahmed A, Johnson CD. Machine learning can improve prediction of severity in acute pancreatitis using admission values of APACHE II score and C-reactive protein. Pancreatology. 2006;6(1-2):123-31. doi: 10.1159/000090032. Epub 2005 Dec 1.
- Background: PubMed 21757970Andersson B, Andersson R, Ohlsson M, Nilsson J. Prediction of severe acute pancreatitis at admission to hospital using artificial neural networks. Pancreatology. 2011;11(3):328-35. doi: 10.1159/000327903. Epub 2011 Jul 9.
- Background: PubMed 31272385Qiu Q, Nian YJ, Guo Y, Tang L, Lu N, Wen LZ, Wang B, Chen DF, Liu KJ. Development and validation of three machine-learning models for predicting multiple organ failure in moderately severe and severe acute pancreatitis. BMC Gastroenterol. 2019 Jul 4;19(1):118. doi: 10.1186/s12876-019-1016-y.
- BackgroundGreedy function approximation: A gradient boostingmachine.
- BackgroundClustering, A. (2009). Clustering Categorical Data Using Hierarchies. Engineering and Technology, 1(2), 334-339.
- BackgroundSilahtaroğlu, G. (2009). An Attribute-Centre Based Decision Tree Classification Algorithm. Engineering and Technology, 302-306.
- BackgroundBentéjac, C., Csörgő, A., & Martínez-Muñoz, G. (2021). A comparative analysis of gradient boosting algorithms. Artificial Intelligence Review, 54(3). https://doi.org/10.1007/s10462-020-09896-5.
- BackgroundBentéjac, C., Csörgő, A., & Martínez-Muñoz, G. (2021). A comparative analysis of gradient boosting algorithms. Artificial Intelligence Review, 54(3). https://doi.org/10.1007/s10462-020-09896-5
- Individual participant dataSharing planned: No
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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.
Gökhan Silahtaroğlu, Prof. principal investigator
Medipol University
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 Acute Pancreatitis and Artificial Intelligence, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 5 May 2021. 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 Turkey (Türkiye). 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?
Accurately estimation of the severity of the disease by machine learning method (time frame: Within a week.). 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 NCT04735055, which also lists 13 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 5 May 2021.