ISRCTN - ISRCTN10525246: Early Achievable SeveritY (EASY) index for simple and accurate early risk stratification in acute pancreatitis

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?
Dr István Hritz
istvan.hritz@freemail.hu

Trial website

http://www.pancreas.hu

Contact information

Type

Scientific

Primary contact

Dr István Hritz

ORCID ID

Contact details

1st Department of Medicine
University of Szeged
Korányi fasor 8
Szeged
6720
Hungary
-
istvan.hritz@freemail.hu

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 measures

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

30/11/2017

Reason abandoned

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

30/11/2017

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