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001-es BibID:BIBFORM070012
035-os BibID:e015874
Első szerző:Márta Katalin
Cím:High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial) : protocol of a multicentre randomized double-blind clinical trial / Katalin Márta, Anikó Nóra Szabó, Dániel Pécsi, Péter Varjú, Judit Bajor, Szilárd Gódi, Patrícia Sarlós, Alexandra Mikó, Katalin Szemes, Mária Papp, Tamás Tornai, Áron Vincze, Zsolt Márton, Patrícia Anna Vincze, Erzsébet Lankó, Andrea Szentesi, Tímea Molnár, Roland Hagendorn, Faluhelyi Nándor, István Battyáni, Dezső Kelemen, Róbert Papp, Attila Miseta, Verzár Zsófia, Markus M. Lerch, Johan P. Neoptoleomos, Miklós Sain-Tóth, Ole H. Petersen, Peter Hegyi
Dátum:2017
ISSN:2044-6055
Megjegyzések:Introduction. Acute pancreatitis (AP) is an inflammatory disease with no specific therapy. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in the pathogenesis. Importantly, preclinical research showed that intracellular ATP delivery restores the physiological function of the cells and protects from cell injury suggesting that restoration of energy levels in the pancreas is therapeutically beneficial. Despite several, high quality and experimental observations in this area, no randomized trials have been conducted to date to address the requirements for energy intake in the early phase of AP. Methods/Design. This is a randomized, controlled two-arms double-blind multicentre trial. Patients suffering from AP will be randomly assigned to groups A (30 kcal/kg/day energy administration starting within 24h of hospital admission) or B (low energy administration during the first 72h of hospital admission). Energy will be delivered with nasoenteric tube feeding with additional intravenous glucose supplementation or total parenteral nutrition if necessary. A combination of multi organ failure for more than 48h and mortality is defined as the primary endpoint, whereas several secondary endpoints such as length of hospitalization or pain will be determined to elucidate more detailed differences between the groups. The general feasibility, safety and quality checks required for high quality evidence will be adhered to.Ethics and Dissemination. The study has been approved by the relevant organization, The Scientific and Research Ethics Committee of the Hungarian Medical Research Council (55961- 2/2016/EKU). This study will provide evidence whether early high-energy nutritional support is beneficial in the clinical management of AP. The results of this trial will be published in an open access way and disseminated among medical doctors.Trial registration: The trial has been registered at the ISRCTN (ISRTCN 63827758).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
acute pancreatitis
energy administration
enteral feeding
randomized clinical trial
Megjelenés:BMJ Open. - 7 : 9 (2017), p. 1-9. -
További szerzők:Szabó Anikó Nóra Pécsi Dániel Varjú Péter Bajor Judit Gódi Szilárd Sarlós Patrícia Mikó Alexandra Szemes Katalin Papp Mária (1975-) (belgyógyász, gasztroenterológus) Tornai Tamás István (1984-) (belgyógyász) Vincze Áron Márton Zsolt Vincze Patrícia Anna Lankó Erzsébet Szentesi Andrea Molnár Tímea Hágendorn Roland Faluhelyi Nándor Battyáni István Kelemen Dezső Papp Róbert Miseta Attila Verzár Zsófia Lerch, Markus M. Neoptoleomos, Johan P. Sain-Tóth, Miklós Petersen, Ole H. Hegyi Péter Jenő (belgyógyász)
Pályázati támogatás:GINOP-2.3.2-15-2016-00015
GINOP
KH-125678
NKFI
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
DOI
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2.

001-es BibID:BIBFORM078557
035-os BibID:(cikkazonosító)e025500
Első szerző:Mikó Alexandra
Cím:Observational longitudinal multicentre investigation of acute pancreatitis. (GOULASH PLUS) : follow-up of the GOULASH-study, protocol / Alexandra Mikó, Bálint Erőss, Patrícia Sarlós, Péter Hegyi Jr., Katalin Márta, Dániel Pécsi, Áron Vincze, Beáta Bódis, Orsolya Nemes, Nándor Faluhelyi, Orsolya Farkas, Róbert Papp, Dezső Kelemen, Andrea Szentesi, Eszter Hegyi, Mária Papp, László Czakó, Ferenc Izbéki, László Gajdán, János Novák, Miklós Sahin-Tóth, Markus M. Lerch, John P. Neoptolemos, Ole H. Petersen, Péter Hegyi
Dátum:2019
ISSN:2044-6055
Megjegyzések:Background: Acute pancreatitis (AP) is an inflammatory condition, which can lead to late consequences. In 20% of patients recurrent AP (RAP) develops and in 7-12.8% chronic pancreatitis (CP) will occur. 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 is 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 i) all severity of pancreatitis are included, ii) patients receive only therapeutic modalities which are accepted by the EBM guideline, iii) whole blood, serum and plasma are stored in our biobank and iv) 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 characterized 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: i) Diet History Questionnaire ii) SF-36 iii) physical activity questionnaire iv) 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 analyzed 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 factors and influencing factors and measurable parameters of CP.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
acute pancreatitis
follow-up
chronic pancreatitis
risk factor
Megjelenés:BMJ Open. - 9 : 8 (2019), p. 1-9. -
További szerzők:Erőss Bálint Sarlós Patrícia Hegyi Péter Jr. (belgyógyász) Márta Katalin Pécsi Dániel Vincze Áron Bódis Beáta Nemes Orsolya Faluhelyi Nándor Farkas Orsolya Papp Róbert Kelemen Dezső Szentesi Andrea Hegyi Eszter Papp Mária (1975-) (belgyógyász, gasztroenterológus) Czakó László Izbéki Ferenc Gajdán László Novák János Sahin-Tóth Miklós Lerch, Markus M. Neoptoleomos, Johan P. Petersen, Ole H. Hegyi Péter Jenő (belgyógyász)
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
DOI
Borító:
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