Please use this identifier to cite or link to this item:
Title: Recurrent acute pancreatitis prevention by the elimination of alcohol and cigarette smoking (REAPPEAR) : protocol of a randomised controlled trial and a cohort study
Author(s): Ocskay, Klementina
Juhász, Márk Félix
Farkas, Nelli
Zádori, Noémi
Szakó, Lajos
Szakács, Zsolt
Szentesi, Andrea
Erőss, Bálint
Miklós, Emöke
Zemplényi, Antal
Birkás, Béla
Csathó, Árpád
Hartung, István
Nagy, Tamás
Czopf, László
Izbéki, Ferenc
Gajdán, László
Papp, Mária
Czakó, László
Illés, Dóra
Marino, Marco V.
Mirabella, Antonello
Małecka-Panas, Ewa
Zatorski, Hubert
Susak, Yaroslav
Opalchuk, Kristina
Capurso, Gabriele
Apadula, Laura
Gheorghe, Cristian
Saizu, Ionut Adrian
Petersen, Ole H.
de-Madaria, Enrique
Rosendahl, Jonas
Párniczky, Andrea
Hegyi, Péter
Issue Date: 2022
Type: Article
Language: English
Abstract: 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.
Open Access: Open access publication
License: (CC BY-NC 4.0) Creative Commons Attribution NonCommercial 4.0(CC BY-NC 4.0) Creative Commons Attribution NonCommercial 4.0
Sponsor/Funder: Publikationsfonds MLU
Journal Title: BMJ open
Publisher: BMJ Publishing Group
Publisher Place: London
Volume: 12
Issue: 1
Original Publication: 10.1136/bmjopen-2021-050821
Appears in Collections:Open Access Publikationen der MLU

Files in This Item:
File Description SizeFormat 
e050821.full.pdf4.22 MBAdobe PDFThumbnail