Clinical trial NCT04647097: Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation
Official title: Recurrent Acute Pancreatitis Prevention by the Elimination of Alcohol and Cigarette Smoking (REAPPEAR): Protocol of a Randomized Controlled Trial and a Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pancreatitis
Recurrent Acute Pancreatitis
Keywords: acute pancreatitis
recurrent acute pancreatitis
smoking
alcohol
lifestyle intervention
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial and a cohort study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* Patient hospitalized with alcohol-induced AP (defined by the revised Atlanta criteria 38)
* Every day smoker (defined as an adult patient who smoked at least 100 cigarettes in his or her lifetime, and now smokes on a daily basis; as per the CDC definition), with at least 1-year history of smoking
* Aged 18-80 years
* Provided written informed consent
* Willing to participate in the intervention in every three months

Exclusion criteria:

* Possible etiologies for AP other than alcohol (eg. gallstone-related, hypertriglyceridemia above 11.5 mM 40-42, hypercalcemia, viral infection) if the etiological cannot be terminated during the index admission (lack of same admission cholecystectomy, familiar hypertrygliceridemia) and cases with combined etiological factors will be excluded
* Untreated, decompensated or severe mMajor psychiatric illnesses (e.g. schizophrenia, bipolar disorder, dementia)
* Currently taking part in a smoking cessation program
* Undergoing active or palliative treatment for malignancy
* Pregnancy, breastfeeding
* Life expectancy is less than two years
* Didn't agreed to participate
* Other

Primary outcomes:
measure: Composite endpoint of recurrence rate of AP and all cause mortality
timeFrame: 24 months
Secondary outcomes:
measure: Recurrence of acute pancreatitis irrespective of etiology
timeFrame: 6, 18,24 months
measure: Recurrence of alcohol-induced AP
timeFrame: 24 months
measure: Likely pancreatitis
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Length of hospital stay
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Presentation to the emergency unit, hospital re-admission
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Development of chronic pancreatitis
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Healthcare cost
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Quality adjusted life years
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Change of alcohol consumption given in gram per week
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Change of tobacco use given in pieces per day
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
measure: Change of alcohol consumption
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 months
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Institute for Translational Medicine, University of Pécs
Study officials:
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