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Research

Early Achievable SeveritY (EASY) index for simple and accurate expedite risk stratification in acute pancreatitis

Project endorsed by IAP Council
Coordinated by: Péter Hegyi, MD, PhD, DSc

Abstract

Background: Acute pancreatitis (AP) is one of the most common diseases of the gastrointestinal tract associated with significant morbidity and mortality. The assessment of severity is crucial in the management of the disease. Current methods of risk stratification in AP have a limited value, as they provide little additional information thus delaying appropriate patient care. Early recognition of severe disease may prevent serious adverse events and improve patient management as well as overall clinical outcome.

Methods/Design: The EASY trial is an observational, multicenter, prospective cohort study for establishing a simple, easy and accurate clinical scoring system for early prognostication of AP. Evaluation of simple attainable potential prognostic parameters obtained at admission (or not later than 6-12 hours afterwards) from patients diagnosed with AP will be performed 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. Comparison of patients’ clinical course with the obtained results of early risk stratification may validate the utilized parameters as prognostic markers. The trial has been (i) discussed and (ii) accepted in a distinguished international scientific meeting, (ii) receiving the relevant ethical approval (TUKEB: 30595-1/2014/EKU), (ii) registered at the ISRCTN registry which is a primary clinical trial registry recognized by WHO (Trial registration number: ISRCTN10525246).

Conclusion: The EASY trial is designed to develop a simple 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.

Hypothesis

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.

Objectives

Our aim is to develop a simple, EASY and accurate clinical scoring system that can be performed also in small hospitals with limited access to diagnostic tools, which can stratify patients with AP during the first 6-12 hours of hospitalization according to their risk for severe disease course. The ability to perform risk stratification of patients earlier and simpler in their disease course would take a major step to improving future management strategies in AP.

We propose an observational, multicenter, prospective cohort trial for establishing a simple, EASY and accurate clinical scoring system for early prognostication of AP.

Population

Patients aged 18 to 99 hospitalized due to acute pancreatitis.

Inclusion Period

Thu 1 January 2015 - Thu 30 November 2017

Clinical End Points

The applicable EASY scoring system may serve as a useful clinical tool at the early phase of the disease course to identify those patients who are at risk of severe morbidity or mortality, since early recognition of severe AP enables clinicians to facilitate proper management thus improve clinical outcome and survival of the patients.

Inclusion and Exclusion 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.

Authorship Rules

First and last authors will be from the Hungarian Pancreatic Study Group. IAP and other scientific societies who might accept to participate, will be listed at the end.

For centres including 30 cases, 1 co-author will be added.

Other contributors (less than 30 cases) will be acknowledged at the end of the manuscript.

Other Information

No other information.

Case Report Form Templates

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References

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