Recurrent acute pancreatitis prevention by the elimination of alcohol and cigarette smoking (REAPPEAR): protocol of a randomised controlled trial and a cohort study

Abstract

Background/objectivesAcute 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 analysisThe 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 disseminationThe 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 numberNCT04647097

In-Hospital Patient Education Markedly Reduces Alcohol Consumption after Alcohol-Induced Acute Pancreatitis

“…A meta-analysis by Platt et al showed that brief advice provided by nurses brings the most favorable outcomes, and Kaner et al also confirmed that a longer duration of counseling probably has no relevant additional effect [ 22 , 23 ]. There are several undergoing randomized clinical trials investigating the effectiveness of the psychological approach on alcohol or smoking habits [ 11 ].…”

“…Longitudinal studies and RCTs are needed to identify the adequate structure and frequency of BIs to achieve alcohol abstinence and minimize the risk of alcohol-induced RAP [ 11 ].…”

“…A significant proportion of etiologies have specific therapies to avoid recurrence, such as cholecystectomy in biliary etiology or fibrate or statin therapy in hyperlipidemic AP and steroid therapy in the case of autoimmune AP [ 6 , 7 , 8 ]. Unfortunately, alcohol-induced pancreatitis stands out in this field, and alcohol-induced AP is by far the most common form of RAP [ 9 , 10 ]; therefore, research on specific therapies for decreasing the number of recurrent alcohol-induced AP is of crucial importance [ 11 , 12 ].…”

Interventions for Pancreatitis—New Approaches, Knowledge Gaps, and Research Opportunities

“…In the future, the implementation of screening tools to identify patients who would benefit from whole-person interventions and implementing multicomponent behavioral interventions are likely to improve the management and QOL in CP. 12 Longitudinal data collection in prospective studies using multiple biomarkers such as brain imaging, quantitative sensory testing, assessment of psychosocial factors, and blood markers may predict progression of CP and aid in identifying patients suitable for whole-person interventions. Specific research methodologies and clinical trial designs to study interconnected systems (eg, machine learning methods, latent class/profile analysis, adaptive interventions) may be particularly pertinent in CP clinical trials.…”

Alcohol consumption and smoking dose-dependently and synergistically worsen local pancreas damage

“…According to Ahmed Ali et al , in a follow-up study of 669 AP patients, smoking represented the dominant risk factor for recurrent AP (RAP) and a combination of alcohol consumption and smoking was the main risk factor for the progression to CP 5. Therefore, cessation programmes and patient education are extremely important means to intervening and lowering the recurrence of AP and the progression to CP 6 7. However, total cessation and abstinence often seems impossible for patients and they do not even try.…”