NCT04735055

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

20 days

First QC Date

September 30, 2020

Last Update Submit

April 30, 2021

Conditions

Keywords

Acute pancreatitis, Artificial intelligence,

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within a week.

Secondary Outcomes (5)

  • Invasive procedure requirement

    Within a week

  • Intensive care unit requirement

    Within a week

  • Survival status

    Within a week

  • Length of hospital stay

    Within a month

  • Number of AP attacks

    After a month of hospital admission as one attack or more than one attack

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute pancreatitis diagnosis according to the Atlanta criteria

You may qualify if:

  • \- Patients with acute pancreatitis diagnosis who admitted to ER within 24 hours after the beginning of abdominal pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University, Gastroenterology Clinic

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 23100216BACKGROUND
  • Fei 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.

    PMID: 30268673BACKGROUND
  • van 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.

    PMID: 24555973BACKGROUND
  • Yoldas 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.

    PMID: 18192888BACKGROUND
  • Pearce 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.

    PMID: 16327290BACKGROUND
  • Andersson 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.

    PMID: 21757970BACKGROUND
  • Qiu 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.

    PMID: 31272385BACKGROUND
  • Greedy function approximation: A gradient boostingmachine.

    BACKGROUND
  • Clustering, A. (2009). Clustering Categorical Data Using Hierarchies. Engineering and Technology, 1(2), 334-339.

    BACKGROUND
  • Silahtaroğlu, G. (2009). An Attribute-Centre Based Decision Tree Classification Algorithm. Engineering and Technology, 302-306.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Gökhan Silahtaroğlu, Prof.

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 30, 2020

First Posted

February 2, 2021

Study Start

September 3, 2020

Primary Completion

September 23, 2020

Study Completion

September 30, 2020

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations