Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol
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...
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BMJ Publishing Group
2019-08-01
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| Online Access: | https://bmjopen.bmj.com/content/9/8/e025500.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Péter Hegyi |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-cdcfd2ec47d84a4599d959fc6edac42d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-08-01 |
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| spelling | doaj-art-cdcfd2ec47d84a4599d959fc6edac42d2024-11-26T14:55:09ZengBMJ Publishing GroupBMJ Open2044-60552019-08-019810.1136/bmjopen-2018-025500Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocolPéter Hegyi0Andrea Szentesi1Eszter Hegyi2Miklós Sahin-Tóth3Patrícia Sarlós4Bálint Erőss5Katalin Márta6Áron Vincze7László Czakó8Mária Papp9Ferenc Izbéki10Markus M Lerch11Ole H Petersen12Dezső Kelemen13Dániel Pécsi14László Gajdán15Alexandra Mikó16Péter Hegyi Jr17Beáta Bódis18Orsolya Nemes19Nándor Faluhelyi20Orsolya Farkas21Róbert Papp22János Novák231 Institute for Translational Medicine, Medical School, University of Pecs, Pecs, Hungary1 Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary1 Center for Exocrine Disorders, Department of Molecular and Cell Biology, Boston University Henry M Goldman School of Dental Medicine, Boston, Massachusetts, USADepartment of Surgery, University of California Los Angeles, Los Angeles, California, USAInstitute for Translational Medicine, University of Pécs Medical School, Pécs, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, HungaryCenter for Traslational Medicine, Semmelweis University, Budapest, Hungary4 Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary6 First Department of Medicine, University of Szeged, Szeged, HungaryDivision of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary5 Szent György University Teaching Hospital of Fejér County, Székesfehérvár, HungaryDepartment of Medicine A, University Medicine Greifswald, Greifswald, Mecklenburg-Vorpommern, GermanyCardiff University, Cardiff, UK23 Surgery Clinic, Pecsi Tudomanyegyetem, Pecs, Hungary2 Division of Gastroenterology, First Department of Medicine, University of Pécs, Pécs, Hungary10 First Department of Gastroenterology, Szent György University Teaching Hospital of Fejér County, Székesfehérvár, Hungary1 Institute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary1 Institute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary5 Division of Endocrinology and Metabolism, First Department of Medicine, University of Pécs, Pécs, Hungary5 Division of Endocrinology and Metabolism, First Department of Medicine, University of Pécs, Pécs, HungaryDepartment of Radiology, Medical School, University of Pécs, Pécs, Hungary6 Department of Radiology, Medical School, University of Pécs, Pécs, Hungary7 Surgery Clinic, University of Pécs, Pécs, Hungary11 First Department of Gastroenterology, Pándy Kálmán Hospital of Békés County, Gyula, HungaryBackground 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 ISRCTN63396106https://bmjopen.bmj.com/content/9/8/e025500.full |
| spellingShingle | 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 Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol BMJ Open |
| title | Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol |
| title_full | Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol |
| title_fullStr | Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol |
| title_full_unstemmed | Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol |
| title_short | Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol |
| title_sort | observational longitudinal multicentre investigation of acute pancreatitis goulash plus follow up of the goulash study protocol |
| url | https://bmjopen.bmj.com/content/9/8/e025500.full |
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