Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation (REAPPEAR)

University of Pecs

Status

Enrolling

Conditions

Recurrent Acute Pancreatitis

Acute Pancreatitis

Treatments

Behavioral: Standard intervention only

Behavioral: Standard intervention plus repeated intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04647097

40394-10/2020/EÜIG

Details and patient eligibility

About

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.

Full 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.

Enrollment

364 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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