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001-es BibID:BIBFORM083103
Első szerző:Koncz Balázs
Cím:LIFEStyle, Prevention and Risk of Acute PaNcreatitis (LIFESPAN) : protocol of a multicentre and multinational observational case-control study / Koncz Balázs, Darvasi Erika, Erdősi Dalma, Szentesi Andrea, Márta Katalin, Erőss Bálint, Pécsi Dániel, Gyöngyi Zoltán, Girán János, Farkas Nelli, Papp Maria, Fehér Eszter, Vitális Zsuzsanna, Janka Tamás, Vincze Áron, Izbéki Ferenc, Dunás-Varga Veronika, Gajdán László, Török Imola, Károly Sándor, Antal Judit, Zádori Noémi, Lerch Markus M., Neoptolemos John, Sahin-Toth Miklos, Petersen Ole H., Hegyi Péter
Dátum:2020
ISSN:2044-6055 2044-6055
Megjegyzések:AbstrACt Introduction Acute pancreatitis (AP) is a life- threatening inflammatory disease of the exocrine pancreas which needs acute hospitalisation. Despite its importance, we have significant lack of knowledge whether the lifestyle factors elevate or decrease the risk of AP or influence the disease outcome. So far, no synthetising study has been carried out examining associations between socioeconomic factors, dietary habits, physical activity, chronic stress, sleep quality and AP. Accordingly, LIFESPAN identifies risk factors of acute pancreatitis and helps to prepare preventive recommendations for lifestyle elements. Methods and analysis LIFESPAN is an observational, multicentre international case?control study. Participating subjects will create case and control groups. The study protocol was designed according to the SPIRIT guideline. Patients in the case group (n=1700) have suffered from AP (alcohol- induced, n=500; biliary, n=500; hypertriglyceridemiainduced, n=200; other, n=500); the control group subjects have no AP in their medical history. Our study will have three major control groups (n=2200): hospital- based (n=500), population- based (n=500) and aetiology- based (alcohol, n=500; biliary, n=500 and hypertriglyceridemia, n=200). All of them will be matched to the case group individually by gender, age and location of residence. Aggregately, 3900 subjects will be enrolled into the study. The study participants will complete a complex questionnaire with the help of a clinical research administrator/study nurse. Analysis methods include analysis of the continuous and categorical values. Ethics and dissemination The study has obtained the relevant ethical approval (54175-2/2018/EKU) and also internationally registered (ISRCTN25940508). After obtaining the final conclusions, we will publish the data to the medical community and will also disseminate our results via open access. trial registration number ISRCTN25940508; Pre- results.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
acute pancreatitis
lifestyle
prevention
Megjelenés:BMJ Open. - 10 : 1 (2020), p. 1-9. -
További szerzők:Darvasi Erika Erdősi Dalma Szentesi Andrea Márta Katalin Erőss Bálint Pécsi Dániel Gyöngyi Zoltán Girán János Farkas Nelli Papp Mária (1975-) (belgyógyász, gasztroenterológus) Fehér Eszter Vitális Zsuzsanna (1963-) (belgyógyász, gasztroenterológus) Janka Tamás Vincze Áron Izbéki Ferenc Dunás-Varga Veronika Gajdán László Török Imola Károly Sándor Antal Judit Zádori Noémi Lerch, Markus M. Neoptoleomos, Johan P. Sahin-Tóth Miklós Petersen, Ole H. Hegyi Péter Jenő (belgyógyász)
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2.

001-es BibID:BIBFORM078558
035-os BibID:(cikkazonosító)e025551 (PMID)31289058 (PMCID)PMC6629406
Első szerző:Kucserik Levente Pál
Cím:Endoscopic sphincterotoMy for delayIng choLecystectomy in mild acute biliarY pancreatitis (EMILY study) : protocol of a multicenter randomized clinical trial / Levente Pál Kucserik, Katalin Márta, Áron Vincze, György Lázár, László Czakó, Zsolt Szentkereszty, Mária Papp, Károly Palatka, Ferenc Izbéki, Áron Altorjay, Imola Török, Sorin Barbu, Marcel Tantau, András Vereczkei, Lajos Bogár, Márton Dénes, Imola Németh, Andrea Szentesi, Noémi Zádori, Judit Antal, Markus M. Lerch, John Neoptolemos, Miklós Sahin-Tóth, Ole H. Petersen, Dezső Kelemen, Péter Hegyi
Dátum:2019
ISSN:2044-6055
Megjegyzések:Introduction. According to the literature, early cholecystectomy is necessary to avoid complications related to gallstones after an initial episode of acute biliary pancreatitis (ABP). A randomized, controlled multicenter trial (the PONCHO trial) revealed that in the case of gallstone-induced pancreatitis, early cholecystectomy was safe in patients with mild gallstone pancreatitis and reduced the risk of recurrent gallstone-related complications, as compared with interval cholecystectomy. We hypothesize that carrying out a sphincterotomy (ES) allows us to delay cholecystectomy, thus making it logistically easier to perform and potentially increasing the efficacy and safety of the procedure. Methods/Design. EMILY is a prospective, randomized, controlled multicenter trial. All patients with mild ABP, who underwent ES during the index admission, or in the medical history will be informed to take part in EMILY study. The patients will be randomized into two groups: (1) early cholecystectomy (within 6 days after discharge) and (2) patients with delayed (interval) cholecystectomy (between 45 and 60 days after discharge). During a 12-month period, 93 patients will be enrolled from participating clinics. The primary endpoint is a composite endpoint of mortality and recurrent acute biliary events (that is, recurrent ABP, acute cholecystitis, uncomplicated biliary colic, and cholangitis). The secondary endpoints are organ failure, biliary leakage, technical difficulty of the cholecystectomy, surgical and other complications. Ethics and dissemination. The trial has been registered at the ISRCTN (ref no. 10667869) and approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (EKU/2018/12176-5).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
acute biliary pancreatitis
cholecystectomy
endoscopic sphincterotomy
Megjelenés:BMJ Open. - 9 : 7 (2019), p. 1-8. -
További szerzők:Márta Katalin Vincze Áron Lázár György Czakó László Szentkereszty Zsolt (1961-) (sebész) Papp Mária (1975-) (belgyógyász, gasztroenterológus) Palatka Károly (1961-) (belgyógyász, gasztroenterológus) Izbéki Ferenc Altorjay Áron Török Imola Barbu, Sorin Tantau, Marcel Vereczkei András Bogár Lajos Dénes Márton Németh Imola Szentesi Andrea Zádori Noémi Antal Judit Lerch, Markus M. Neoptoleomos, Johan P. Sahin-Tóth Miklós Petersen, Ole H. Kelemen Dezső Hegyi Péter Jenő (belgyógyász)
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3.

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
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4.

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)
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5.

001-es BibID:BIBFORM100014
035-os BibID:(cikkazonosító)e050821 (WoS)000739490700018 (Scopus)85122762723
Első szerző:Ocskay Klementina
Cím:Recurrent acute pancreatitis prevention by the elimination of alcohol and cigarette smoking (REAPPEAR) : protocol of a randomised controlled trial and a cohort study / Klementina Ocskay, Márk Félix Juhász, Nelli Farkas, Noémi Zádori, Lajos Szakó, Zsolt Szakács, Andrea Szentesi, Bálint Erőss, Emőke Miklós, Antal Zemplényi, Béla Birkás, Árpád Csathó, István Hartung, Tamás Nagy, László Czopf, Ferenc Izbéki, László Gajdán, Mária Papp, László Czakó, Dóra Illés, Marco V. Marino, Antonello Mirabella, Ewa Małecka-Panas, Hubert Zatorski, Yaroslav Susak, Kristina Opalchuk, Gabriele Capurso, Laura Apadula, Cristian Gheorghe, Ionut Adrian Saizu, Ole H. Petersen, Enrique de-Madaria, Jonas Rosendahl, Andrea Párniczky, Péter Hegyi, Hungarian Pancreatic Study Group
Dátum:2022
ISSN:2044-6055
Megjegyzések:Background/objectives Acute recurrent pancreatitis (ARP) due to alcohol and/or tobacco abuse is a preventable disease which lowers quality of life and can lead to chronic pancreatitis. The REAPPEAR study aims to investigate whether a combined patient education and cessation programme for smoking and alcohol prevents ARP. Methods and analysis The REAPPEAR study consists of an international multicentre randomised controlled trial (REAPPEAR-T) testing the efficacy of a cessation programme on alcohol and smoking and a prospective cohort study (REAPPEAR-C) assessing the effects of change in alcohol consumption and smoking (irrespective of intervention). Daily smoker patients hospitalised with alcohol-induced acute pancreatitis (AP) will be enrolled. All patients will receive a standard intervention priorly to encourage alcohol and smoking cessation. Participants will be subjected to laboratory testing, measurement of blood pressure and body mass index and will provide blood, hair and urine samples for later biomarker analysis. Addiction, motivation to change, socioeconomic status and quality of life will be evaluated with questionnaires. In the trial, patients will be randomised either to the cessation programme with 3-monthly visits or to the control group with annual visits. Participants of the cessation programme will receive a brief intervention at every visit with direct feedback on their alcohol consumption based on laboratory results. The primary endpoint will be the composite of 2-year all-cause recurrence rate of AP and/ or 2-year all-cause mortality. The cost-effectiveness of the cessation programme will be evaluated. An estimated 182 participants will be enrolled per group to the REAPPEAR-T with further enrolment to the cohort. Ethics and dissemination The study was approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (40394-10/2020/ EÜIG), all local ethical approvals are in place. Results will be disseminated at conferences and in peer-reviewed journals. Trial registration number NCT04647097
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:BMJ Open. - 12 : 1 (2022), p. 1-9. -
További szerzők:Juhász Márk Félix Farkas Nelli Zádori Noémi Szakó Lajos Szakács Zsolt Szentesi Andrea Erőss Bálint Miklós Emőke Zemplényi Antal Birkás Béla Csathó Árpád Hartung István Nagy Tamás (1977-) (vegyész, orvosi laboratóriumi analitikus) Czopf László Izbéki Ferenc Gajdán László Papp Mária (1975-) (belgyógyász, gasztroenterológus) Czakó László Illés Dóra Marino, Marco Vito Mirabella, Antonello Małecka-Panas, Ewa Zatorski, Hubert Susak, Yaroslav Mykhailovych Opalchuk, Kristina Capurso, Gabriele Apadula, Laura Gheorghe, Cristian Saizu, Ionut Adrian Petersen, Ole H. de-Madaria, Enrique Rosendahl, Jonas Párniczky Andrea (gyermekgyógyász) Hegyi Péter Jenő (belgyógyász) Hungarian Pancreatic Study Group
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6.

001-es BibID:BIBFORM117716
Első szerző:Torp, Nikolaj
Cím:Personalised human albumin in patients with cirrhosis and ascites : design and rationale for the ALB-TRIAL - a study protocol of a randomised clinical biomarker validation trial / Nikolaj Torp, Mads Israelsen, Minneke Coenraad, Maria Papp, Debbie L. Shawcross, Marko Korenjak, Paolo Angeli, Wim Laleman, Adria Juanola, Pere Gines, Jonel Trebicka, Alexander Krag, MINCROB-PREDICT Consortium
Dátum:2024
ISSN:2044-6055
Megjegyzések:Abstract Introduction; Human albumin is used in the treatment of complications of cirrhosis. However, the use of long-term human albumin administration is costly and resource demanding for both patients and healthcare systems. A precision medicine approach with biomarkers to predict human albumin treatment response, so called predictive biomarkers, could make this a viable treatment option in patients with cirrhosis and ascites. Methods and analysis; ALB-TRIAL is a multinational, double-blind, placebo-controlled randomised controlled rial. We aim to validate a predictive biomarker, consisting of a panel of circulating metabolites, to predict the treatment response to human albumin in patients with cirrhosis and ascites. All enrolled patients are stratified into a high- or low expected effect stratum of human albumin based on the biomarker outcome. After stratification, patients in each group are randomised into either active treatment (20% human albumin) or corresponding placebo (0.9% NaCl) every 10th day for 6 months. The primary outcome is the cumulative number of liver-related events (composite of decompensation episodes, transjugular intrahepatic shunt insertion, liver transplantation and death). Key secondary outcomes include time-to-event analysis of primary outcome components, an analysis of the total healthcare burden and a health economic analysis. Ethics and dissemination; The trial obtained ethical- and regulatory approval in Denmark, Germany, the Netherlands, Belgium, Hungary and Spain through the Clinical Trials Information System (CTIS) from 13 February 2023, while United Kingdom approvals from the Health Regulatory Authority (HRA), Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) are pending. Findings will be published in peer-reviewed journals, presented at conferences, communicated to relevant stakeholders and in the public registry of CTIS, following trial completion.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
cirrhosis
biomarker
RCT
validation
ascites
albumin
personalised medicine protocol
Megjelenés:BMJ Open. - "Accepted by Publisher" (2024). -
További szerzők:Israelsen, Mads Coenraad, Minneke Papp Mária (1975-) (belgyógyász, gasztroenterológus) Shawcross, Debbie L. Korenjak, Marko Angeli, Paolo Laleman, Wim Juanola, Adria Ginès, Pere Trebica, Jonel Krag, Aleksander MINCROB-PREDICT Consortium
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