Early Achievable SeveritY (EASY) index for simple and accurate early risk stratification in acute pancreatitis
| ISRCTN | ISRCTN10525246 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10525246 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/11/2014
- Registration date
- 28/11/2014
- Last edited
- 08/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 May 2024 (updated 03/01/2020, previously: 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
Contact information
Scientific
1st Department of Medicine
University of Szeged
Korányi fasor 8
Szeged
6720
Hungary
| kubali@gmail.com |
Study information
| Study design | Observational multicenter prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Early Achievable SeveritY (EASY) index for simple and accurate early risk stratification in acute pancreatitis: an observational multicenter prospective cohort study |
| Study acronym | EASY |
| Study objectives | 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(s) | The National Hungarian Ethical Authority (ETT TUKEB), No. 30595-1/2014/EKU |
| Health condition(s) or problem(s) studied | 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 | Other |
| 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 study start date | 01/12/2014 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 1200 |
| Total final enrolment | 1184 |
| Key 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 |
| Key exclusion criteria | N/A |
| Date of first enrolment | 01/12/2014 |
| Date of final enrolment | 30/01/2024 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Szeged
6720
Hungary
Sponsor information
Research organisation
Korányi fasor 8
Szeged
6720
Hungary
| hpsg.info@gmail.com | |
| Website | http://www.pancreas.hu |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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 |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2015 | Yes | No | |
| Results article | 01/06/2022 | 08/06/2022 | Yes | No |
Editorial Notes
08/06/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
03/01/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/01/2019 to 30/01/2024.
2. The overall end date was changed from 31/05/2019 to 31/05/2024.
3. The intention to publish date was changed from 31/07/2019 to 31/05/2025.
4. The plain English summary was updated to reflect these changes.
19/02/2018: The overall trial end date has been updated from- 30/11/2017 to 31/05/2019. The recruitment end date has been updated from 30/11/2017 to 30/01/2019. Dr István Hritz 9istvan.hritz@freemail.hu) has been removed from the study contact and Balázs Kui, MD, PhD (k.kubali@gmail.com) has been added.
