Plain English Summary
Background and study aims
Acute pancreatitis (AP) is a serious condition where the pancreas becomes inflamed over a short period of time. Assessing the severity is crucial to the management of the disease. Current methods of determining the level of risk (risk stratification) in AP have a limited value as they provide little additional information and thus may delay appropriate management. Early recognition of severe disease may prevent serious adverse events and improve patient management as well as overall clinical outcome. Our aim is to develop a simple, easy and accurate clinical scoring system that can stratify patients with AP during the first 6-12 hours of hospitalization according to their risk for severe disease course, and which can also be performed in small hospitals with limited access to diagnostic tools.
Who can participate?
Patients aged 18 to 99 hospitalized due to acute pancreatitis.
What does the study involve?
This is an observational study where information from the patients’ medical history, physical examination, laboratory tests and diagnostic imaging will be evaluated. The care or services that patients receive will not be altered by the study. All patients will be treated equally, according to the recently published guidelines.
What are the possible benefits and risks of participating?
Our goal is to develop a simple and accurate clinical scoring system for patient stratification. The ability to perform earlier and simpler risk stratification may prevent serious adverse events and improve patient management as well as overall clinical outcome. Because of the characteristics of the observation study there will be no risks of participation related to the trial.
Where is the study run from?
University of Szeged (Hungary)
When is the study starting and how long is it expected to run for?
December 2014 to November 2017.
Who is funding the study?
Hungarian Pancreatic Study Group (HPSG) (Hungary).
Who is the main contact?
Balázs Kui, MD, PhD
k.kubali@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Balázs Kui
ORCID ID
Contact details
1st Department of Medicine
University of Szeged
Korányi fasor 8
Szeged
6720
Hungary
-
kubali@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Early Achievable SeveritY (EASY) index for simple and accurate early risk stratification in acute pancreatitis: an observational multicenter prospective cohort study
Acronym
EASY
Study hypothesis
Acute pancreatitis is one of the most common diseases of the gastrointestinal tract that requires acute hospitalization and despite the special care is still associated with significant morbidity and mortality worldwide. The assessment of severity is a crucial issue in the management of acute pancreatitis. It is critical to identify patients who are at high risk for severe disease course, since they require close monitoring and immediate aggressive treatment.
Early recognition of severe acute pancreatitis by a simple, easy and accurate clinical scoring system for early prognostication of the disease may prevent serious adverse events and improve patient management as well as overall clinical outcome.
Ethics approval
The National Hungarian Ethical Authority (ETT TUKEB), No. 30595-1/2014/EKU
Study design
Observational multicenter prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute pancreatitis
Intervention
The web-based Hungarian National Pancreas Registry would provide the background for data management of this trial. Simple attainable potential prognostic parameters from medical history, physical examination, laboratory tests and diagnostic imaging obtained at admission from patients diagnosed with acute pancreatitis will be evaluated to assess their potential correlation with the disease severity. The selected parameters that show the strongest correlation with severe disease course will be further utilized as potential early severity prognostic markers for prospective new patient stratification. The comparison of patients clinical course with the obtained results of early risk stratification in case of correlation may validate the utilized parameters as prognostic markers.
Intervention type
Phase
Drug names
Primary outcome measure
Validation of previously selected parameters that showed the strongest correlation with severe disease course as prognostic markers to develop a simple, easy and accurate clinical scoring system that can stratify patients with acute pancreatitis during the first 6-12 hours of hospitalization according to their risk for severe disease course.
Secondary outcome measures
N/A
Overall trial start date
01/12/2014
Overall trial end date
31/05/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients (men and women aged 18 to 99 years) hospitalized due to acute pancreatitis diagnosed based on the fulfillment of two out of three of the criteria irrespectively of the etiology
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1200
Participant exclusion criteria
N/A
Recruitment start date
01/12/2014
Recruitment end date
30/01/2019
Locations
Countries of recruitment
Hungary
Trial participating centre
University of Szeged
1st Department of Medicine
Szeged
6720
Hungary
Sponsor information
Organisation
Hungarian Pancreatic Study Group (HPSG)
Sponsor details
Korányi fasor 8
Szeged
6720
Hungary
-
hpsg.info@gmail.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Hungarian Pancreatic Study Group (HPSG)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The prestudy protocol was published in June 2015 in the Journal of Gastrointestinal and Liver Diseases:
http://jgld.ro/2015/2/12.pdf
Intention to publish date
31/07/2019
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26114177