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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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