Hungarian Pancreatic Study Group – Magyar Hasnyálmirigy Munkacsoport

1. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EarlyAchievableSeveritYIndex InAcutePancreatitis CLINICAL TRIALS ORGANIZED BY HPSG EarlyAchievableSeveritY Index InAcutePancreatitis EASY Andrea Szentesi SZEGED, HUNGARY on behalf of the Hungarian Pancreatic Study Group HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

2. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis TRIAL PREPARATION • The protocol have been discussedin 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 (ISRCTN10525246) 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 (16.06.2015) • The study is open for all centersthroughout 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: 177-182 *http://pancreas.hu/sites/info/files/conferences/ALPD2014-Program.pdf HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

3. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis AcutePancreatitis BACKGROUND • 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 allcases (mortalityupto 50%) • Patients who are at high risk for severe disease course require close monitoring and immediate aggressive treatment EARLY assessment of severity is crucial in the management of the disease! Banks PA et al. Gut. 2013;62(1):102-111. HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

4. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis Prognostication of AP BACKGROUND Existingpredictivescoringsystems Ranson Glasgow APACHE II • 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 BISAP HAPS • 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! HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

5. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis 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 HYPOTHESIS 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 AIM HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

6. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis STRUCTURE Enrollment of patients with acute pancreatitis • prospective • multicenter Data collection and evaluation • simple attainable potential prognostic parameters at admission • individual statistical analysis of each parameter to assess its potential correlation with disease severity 900 patients • 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 Utilization of potential prognostic markers 300 patients EASY Index 5-10 parameters Validation of the EASY index Validation of utilizedparametersasprognosticmarkers:incase of correlationofpatients’ clinicalcoursewiththeobtainedresultsofprospective (early) riskstratification HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

7. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis FORMS www.pancreas.hu HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

8. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis FORMS www.pancreas.hu Studies EASY • All forms are available in English and Russian • Romanian and Serbian translations are in process HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

9. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis ELECTRONIC DATA ADMINISTRATION SYSTEM HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

10. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis DATA QUALITY CONTROL 1. administrator or doctor 2. local doctor 3. central admin control 4. principal investigator Important! Checking, completing, correcting Incomplete from will be excluded! approved rejected with a note HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

11. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis ENROLLED PATIENTS 201 initiatedForm A uploads 52 38 111 • Important! • to finish drafts ASAP • to complete all Form Bs • to approve forms 163 HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

12. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis Mures County Emergency Hospital, Romania CENTERS 34 Helsinki University Central Hospital, Finland 13 Vilnius University Hospital Santariskiu Klinikos, Lithuania 22 19 University of Szeged, Hungary HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

13. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis TIPICAL MISTAKES • 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 HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

14. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis FURTHER GENETIC STUDIES 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 www.pancreas.hu / Registry for Pancreatic Patients / RPP Forms • Coding, storing (-20°C) • Delivey to Szeged HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

15. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis SUMMARY • Letter of IntenttoJoin • Patientsabove 18 • Informedconsentform • Enrollmentinthefirst 12 hours– EmergencyUnits! • Detailedquestionnaireatadmission + dailyquestionnaires • Open forallcenters - 28 joinedcenters, (14 active) • Forfurthergeneticstudies • General registryinformedconsentforms • Bloodsamples ALL THE FORMS AND THE STUDY PROTOCOLS ARE AVAILABLE ON THE WEBPAGE: www.pancreas.hu HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport

16. 4thConference of theHungarian & 2ndConference of theEastern and Central European PancreaticStudyGroups EASY EASY EarlyAchievableSeveritYIndex InAcutePancreatitis Thankyoufor yourattention! THE HUNGARIAN PANCREATIC STUDY GROUP IS COMMITTED TO IMPROVING THE LIVE OF PATIENTS SUFFERING FROM PANCREATIC DISEASES! www.pancreas.hu HungarianPancreaticStudy Group – Magyar Hasnyálmirigy Munkacsoport