Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport Andrea Szentesi on behalf of the Hungarian Pancreatic Study Group SZEGED, HUNGARY EASY Early Achievable SeveritY Index In Acute Pancreatitis Early Achievable SeveritY Index In Acute Pancreatitis EASY 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY  The protocol have been discussed in our latest international meeting* held in Szeged, November 2014, where expert pancreatologists attended.  The study has received the relevant ethical approval (No. ad.30595/2014) issued by the National Hungarian Ethical Authority (ETT TUKEB).  The study has been registered at the ISRCTN registry (ISRCTN ) which is a primary clinical trial registry recognized by WHO and ICMJE.  The IAP Scientific Committee has approved the study and advertised worldwide among its 4000 members ( )  The study is open for all centers throughout the world.  Electronic CRF has been developed.  The prestudy protocol has been published in the Journal of Gastrointestinal and Liver Diseases, June 2015 Vol. 24 No 2: *

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Acute pancreatitis (AP) is a common disease of the gastrointestinal tract and AP is associated with significant morbidity and mortality  The revised Atlanta Classification recognizes three degrees of severity: mild, moderate and severe  Majority of cases are categorized as mild or moderately severe, severe being 15-20% of all cases (mortality up to 50%)  Patients who are at high risk for severe disease course require close monitoring and immediate aggressive treatment Acute Pancreatitis Banks PA et al. Gut. 2013;62(1): EARLY assessment of severity is crucial in the management of the disease! EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY Existing predictive scoring systems Prognostication of AP RansonGlasgow BISAP APACHE II HAPS Data not routinely collected at admission Require 48 hours to be completed Missing the early therapeutic window Developed as intensive care tool Requires large number of parameters Sometimes not relevant to prognosis in AP Simple system for early prediction of persistent organ failure and mortality Cannot easily distinguish between transient and persistent organ failure Not widely utilized in general practice Can predict a non-severe disease course with 96-97% specificity with a PPV of 98% Cannot distinguish between the moderate and severe disease course; not widely utilized in practice These limitations might have an impact on appropriate disease management and may influence patient survival!

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY 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 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

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Enrollment of patients with acute pancreatitis  simple attainable potential prognostic parameters at admission  individual statistical analysis of each parameter to assess its potential correlation with disease severity Data collection and evaluation Utilization of potential prognostic markers Validation of the EASY index  prospective  multicenter Validation of utilized parameters as prognostic markers: in case of correlation of patients’ clinical course with the obtained results of prospective (early) risk stratification EASY Index 5-10 parameters  Potential (early) severity prognostic markers: parameters that show strongest correlation with severe disease course of AP  Utilization of assessed markers: application of selected parameters for prospectively enrolled new patients’ stratification  Evaluation of utilization: comparison of patients’ clinical course with the obtained results of early risk stratification 900 patients 300 patients Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY EASY  All forms are available in English and Russian  Romanian and Serbian translations are in process

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY 1. administrator or doctor 2. local doctor 4. principal investigator approved rejected with a note Important! Checking, completing, correcting Incomplete from will be excluded! 3. central admin control

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY 201 initiated Form A uploads Important!  to finish drafts ASAP  to complete all Form Bs  to approve forms

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY InstitutionPatients Country City 1 Mures County Emergency Hospital34 Romania Targu Mures 2 Vilnius University Hospital Santariskiu Klinikos22 Lithuania Vilnius 3 University of Szeged19 Hungary Szeged 4 Hospital of Helsinki University Central Hospital13 Finland Helsinki 5 Gomel Regional Clinical Hospital8 Belarus Gomel 6 Vitkovicka Nemocnice A. S.6 Czech Republic Ostrava 7 Hospital of Medical Academy named after SI Georgievsky5 Russia Simferopol 8 Saint-Luke Clinical Hospital4 Russia St Petersburg Semmelweis University, Second Department of Medicine Hungary Budapest Bohomolets National Medical University Ukraine Kiev S. Andrea Hospital University "Sapienza" Italy Rome Helsinki University Central Hospital, Finland University of Szeged, Hungary Mures County Emergency Hospital, Romania Vilnius University Hospital Santariskiu Klinikos, Lithuania

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY Forms not completed or approved B Forms missing Detailed info missing alcohol consumption abdominal pain (e.g. since when?) Imaging examination description missing Epicrisis missing

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY If you want the patient to take part in further genetic studies, you can upload data easily to the general registry. General registry informed consent form / Registry for Pancreatic Patients / RPP Forms  Coding, storing (-20°C)  Delivey to Szeged

Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY Early Achievable SeveritY Index In Acute Pancreatitis 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups EASY  Letter of Intent to Join  Patients above 18  Informed consent form  Enrollment in the first 12 hours – Emergency Units!  Detailed questionnaire at admission + daily questionnaires  Open for all centers - 28 joined centers, (14 active)  For further genetic studies  General registry informed consent forms  Blood samples ALL THE FORMS AND THE STUDY PROTOCOLS ARE AVAILABLE ON THE WEBPAGE:

THE HUNGARIAN PANCREATIC STUDY GROUP IS COMMITTED TO IMPROVING THE LIVE OF PATIENTS SUFFERING FROM PANCREATIC DISEASES! Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport EASY 4 th Conference of the Hungarian & 2 nd Conference of the Eastern and Central European Pancreatic Study Groups Early Achievable SeveritY Index In Acute Pancreatitis