Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary.
Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.
BMJ Open. 2022 Jan 4;12(1):e050821. doi: 10.1136/bmjopen-2021-050821.
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.
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.
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.
NCT04647097.
背景/目的：由于酗酒和/或吸烟导致的急性复发性胰腺炎（ARP）是一种可预防的疾病，它会降低生活质量，并可能导致慢性胰腺炎。REAPPEAR 研究旨在探讨针对吸烟和饮酒的综合患者教育和戒除方案是否可以预防 ARP。
REAPPEAR 研究包括一项国际多中心随机对照试验（REAPPEAR-T），该试验测试了戒烟和戒酒方案的疗效，以及一项前瞻性队列研究（REAPPEAR-C），该研究评估了饮酒和吸烟习惯改变的效果（无论干预与否）。每天吸烟的因酒精引起的急性胰腺炎（AP）住院患者将被纳入研究。所有患者将接受标准干预以鼓励他们戒烟戒酒。参与者将接受实验室检查、血压和体重指数测量，并提供血液、头发和尿液样本，以备日后进行生物标志物分析。使用问卷评估成瘾、改变动机、社会经济地位和生活质量。在试验中，患者将被随机分配到 3 个月一次就诊的戒除方案组或每年一次就诊的对照组。参加戒除方案的患者将在每次就诊时接受简短干预，并根据实验室结果直接反馈他们的饮酒情况。主要终点是 2 年内所有原因的 AP 复发率和/或 2 年内所有原因的死亡率的复合结果。将评估戒除方案的成本效益。预计每组将有 182 名参与者被纳入 REAPPEAR-T 研究，同时还将有更多的参与者被纳入队列研究。
该研究已获得匈牙利医学研究委员会科学和研究伦理委员会的批准（40394-10/2020/EÜIG），所有地方伦理批准均已到位。研究结果将在会议和同行评议期刊上发表。
NCT04647097。
