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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.
Trial registration number NCT04647097
- pancreatic disease
- substance misuse
- preventive medicine
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AP and PH contributed equally.
Contributors All authors were involved in the study design and edited the manuscript. KOc conducted the literature search, conceptualised and wrote the manuscript and prepared the figures. FJ participated in manuscript writing, critical revision, abstract writing and figure preparation. NF performed the sample size calculation and planned the statistical analyses. NZ and LS facilitated the ethical approval and trial registration. ZS provided methodological guidance, critically reviewed and revised the manuscript, EM facilitated patient invovlement and will coordinate data management, BB, AC and IH designed the intervention and chose the questionnaires, AZ will carry out the healthcare cost calculations. LC provided expert opinion and will perform safety monitoring. TN provided expert opinion on laboratory measurements and biological sample collection. FI, LG, MP, LC, DI, MVM, AM, EM-P, HZ, YS, KOp, GC, LA, CG and IAS provided insight on feasibility and will coordinate local enrolment and follow-up. OHP, Ed-M and JR provided expert opinion. PH, AP, AS, BE critically reviewed and revised the manuscript. PH and AP have given significant intellectual input and supervised the work. All authors have read and approved the final version of the manuscript. AP and PH co-supervised this work as joint last authors.
Funding Center costs (IT, biostatistics, trial organisation, etc) are covered by the University of Pécs Medical School (grant number: not applicable). This work was supported by 'GINOP-2.3.2-15-2016-00048 - STAY ALIVE' (PH) cofinanced by the European Union (European Regional Development Fund) within the framework of Programme Széchenyi 2020, and by EFOP 3.6.2‐16‐2017‐00006 – LIVE LONGER (PH) Human Resources Development Operational Programme Grant which is cofinanced by the European Union (European Regional Development Fund) within the framework of Programme Széchenyi 2020 as well as the Translational Medicine Foundation. Further grants: a János Bolyai Research Scholarship from the Hungarian Academy of Sciences (AP) and National Research, Development and Innovation Office Project Grants (K116634, (PH);, FK138929 (AP)).
Disclaimer The sponsor was not involved in the design of the study and will have no access to the database or the randomisation code.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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