Recurrent Acute Pancreatitis Prevention by the Elimination of Alcohol and Cigarette Smoking (REAPPEAR): Protocol of a Randomized Controlled Trial and a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 364
- 试验地点
- 2
- 主要终点
- Composite endpoint of recurrence rate of AP and all cause mortality
研究概览
简要总结
Recurrence of acute pancreatitis (AP) is often facilitated by regular alcohol consumption and smoking. An applied lifestyle intervention focusing on the cessation of alcohol consumption and smoking might prevent the recurrence of AP. REAPPEAR Study is a randomized controlled trial and a cohort study focusing on the efficacy of the lifestyle intervention and the effect of quitting alcohol and smoking respectively.
详细描述
Alcohol and smoking caused recurrent acute pancretitis might be prevented. The condition is known for it's causative effect of chronic pancreatitis and nonbeneficial effect on quality of life. Clinical equipoise regarding the impact of alcohol and smoking cessation still exists, due to the non existence of well designed clinical trials. The aim of the REAPPEAR study is to investigate the effect of cessation program of alcohol and tobacco use on the recurrence of acute pancreatitis.
The REAPPEAR Study is a combined clinical trial involving a randomized multicenter clinical trial (REAPPEAR-T), which assesses the effect of the cessation program on the recurrence of the acute pancreatitis, and a cohort analysis, which investigates the effect of smoking and alcohol cessation on the recurrance of acute pancreatitis. Daily smokers, hospitalized with alcohol-induced pancreatitis will be included in the trial. Standard cessational intervention will be provided for all patients before enrollment. Laboratory testing, measurement of blood pressure and BMI will be performed, while also hair, urine samples and blood will be retrieved for later biomarker measurement. The evaluation of motivation to change, addiction, quality of life and socioeconomic status will be recorded at every visit, which will take place every 3 months or yearly according to the random allocation. For patients, who present at visit of every 3 months a brief intervention will be provided, together with a laboratory testing to provide feedback. The primary composite endpoint of this study will be the recurrence rate of acute pancreatitis irrespective of etiology and all-cause mortality in a 2 year timeframe. The cost-effectiveness will be also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessors of the outcomes will be blinded regarding allocation. The medical team providing the visits and treatment during hospitalization rwill not be aware of the allocation. Patients and the study nurse can not be blinded, due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composite endpoint of recurrence rate of AP and all cause mortality
时间窗: 24 months
Recurrence rate of AP irrespective of etiology and all cause mortality. The diagnosis of AP based on the two out of three rule. (At least 2 of 3 typical features are present -upper abdominal pain, elevation of serum pancreatic enzymes at least 3 times the reference value, and imaging findings consistent with AP.)
次要结局
- Healthcare cost(3, 6, 9, 12, 15, 18, 21, 24 months)
- Length of hospital stay(3, 6, 9, 12, 15, 18, 21, 24 months)
- Development of chronic pancreatitis(3, 6, 9, 12, 15, 18, 21, 24 months)
- Recurrence of acute pancreatitis irrespective of etiology(6, 18,24 months)
- Recurrence of alcohol-induced AP(24 months)
- Likely pancreatitis(3, 6, 9, 12, 15, 18, 21, 24 months)
- Quality adjusted life years(3, 6, 9, 12, 15, 18, 21, 24 months)
- Change of alcohol consumption given in gram per week(3, 6, 9, 12, 15, 18, 21, 24 months)
- Change of alcohol consumption(3, 6, 9, 12, 15, 18, 21, 24 months)
- Presentation to the emergency unit, hospital re-admission(3, 6, 9, 12, 15, 18, 21, 24 months)
- Change of tobacco use given in pieces per day(3, 6, 9, 12, 15, 18, 21, 24 months)
研究者
Dr Hegyi Péter
Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs
University of Pecs