Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol
Péter Hegyi,
Andrea Szentesi,
Eszter Hegyi,
Miklós Sahin-Tóth,
Patrícia Sarlós,
Bálint Erőss,
Katalin Márta,
Áron Vincze,
László Czakó,
Mária Papp,
Ferenc Izbéki,
Markus M Lerch,
Ole H Petersen,
Dezső Kelemen,
Dániel Pécsi,
László Gajdán,
Alexandra Mikó,
Péter Hegyi Jr,
Beáta Bódis,
Orsolya Nemes,
Nándor Faluhelyi,
Orsolya Farkas,
Róbert Papp,
János Novák
Affiliations
Péter Hegyi
1 Institute for Translational Medicine, Medical School, University of Pecs, Pecs, Hungary
Andrea Szentesi
1 Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary
Eszter Hegyi
1 Center for Exocrine Disorders, Department of Molecular and Cell Biology, Boston University Henry M Goldman School of Dental Medicine, Boston, Massachusetts, USA
Miklós Sahin-Tóth
Department of Surgery, University of California Los Angeles, Los Angeles, California, USA
Patrícia Sarlós
Institute for Translational Medicine, University of Pécs Medical School, Pécs, Hungary
Bálint Erőss
Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
Katalin Márta
Center for Traslational Medicine, Semmelweis University, Budapest, Hungary
Áron Vincze
4 Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
László Czakó
6 First Department of Medicine, University of Szeged, Szeged, Hungary
Mária Papp
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary
Ferenc Izbéki
5 Szent György University Teaching Hospital of Fejér County, Székesfehérvár, Hungary
Markus M Lerch
Department of Medicine A, University Medicine Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany
Ole H Petersen
Cardiff University, Cardiff, UK
Dezső Kelemen
23 Surgery Clinic, Pecsi Tudomanyegyetem, Pecs, Hungary
Dániel Pécsi
2 Division of Gastroenterology, First Department of Medicine, University of Pécs, Pécs, Hungary
László Gajdán
10 First Department of Gastroenterology, Szent György University Teaching Hospital of Fejér County, Székesfehérvár, Hungary
Alexandra Mikó
1 Institute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
Péter Hegyi Jr
1 Institute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
Beáta Bódis
5 Division of Endocrinology and Metabolism, First Department of Medicine, University of Pécs, Pécs, Hungary
Orsolya Nemes
5 Division of Endocrinology and Metabolism, First Department of Medicine, University of Pécs, Pécs, Hungary
Nándor Faluhelyi
Department of Radiology, Medical School, University of Pécs, Pécs, Hungary
Orsolya Farkas
6 Department of Radiology, Medical School, University of Pécs, Pécs, Hungary
Róbert Papp
7 Surgery Clinic, University of Pécs, Pécs, Hungary
János Novák
11 First Department of Gastroenterology, Pándy Kálmán Hospital of Békés County, Gyula, Hungary
Background Acute pancreatitis (AP) is an inflammatory condition that can lead to late consequences. Recurrent AP (RAP) develops in 20% of patients and chronic pancreatitis (CP) occurs in 7%–12.8%. However, we do not have sufficient information to establish an evidence-based statement to define early CP, or how to prevent its development.Aim The aim of this study was to understand the influencing factors and to determine which parameters should be measured or used as a biomarker to detect the early phase of CP.Methods/Design This is an observational prospective follow-up study of the GOULASH-trial (ISRTCN 63827758) in which (1) all severity of pancreatitis are included; (2) patients receive only therapeutic modalities which are accepted by the evidence based medicine (EBM) guideline; (3) whole blood, serum and plasma samples are stored in our biobank; and (4) large amount of variables are collected and kept in our electronic database including anamnestic data, physical examination, laboratory parameters, imaging, therapy and complications. Therefore, this fully characterised patient cohort are well suitable for this longitudinal follow-up study. Patients’ selection: patients enrolled in the GOULASH study will be offered to join to the longitudinal study. The follow-up will be at 1, 2, 3, 4, 5 and 6 years after the episode of AP. Anamnestic data will be collected by questionnaires: (1) diet history questionnaire, (2) 36-Item Short-Form Health Survey, (3) physical activity questionnaire and (4) stress questionnaire. Genetic tests will be performed for the genes associated with CP. The exocrine and endocrine pancreatic, liver and kidney functions will be determined by laboratory tests, stool sample analyses and imaging. Cost-effectiveness will be analysed to examine the relationship between events of interest and health-related quality of life or to explore subgroup differences.Conclusion This study will provide information about the risk and influencing factors leading to CP and identify the most useful measurable parameters.Trial registration number ISRCTN63396106
