Cessation of alcohol and smoking to prevent acute pancreatitis recurrence
Recurrent Acute Pancreatitis Prevention by the Elimination of Alcohol and Cigarette Smoking (REAPPEAR): Protocol of a Randomized Controlled Trial and a Cohort Study
NA · University of Pecs · NCT04647097
This study is testing whether quitting alcohol and smoking can help people who have had acute pancreatitis avoid getting it again.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 364 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pecs (other) |
| Locations | 1 site (Pécs) |
| Trial ID | NCT04647097 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a lifestyle intervention aimed at preventing the recurrence of acute pancreatitis by promoting the cessation of alcohol consumption and smoking. It includes a randomized controlled trial and a cohort analysis to assess the impact of these lifestyle changes on patients hospitalized with alcohol-induced pancreatitis. Participants will receive standard cessation interventions and will be monitored for changes in motivation, addiction, quality of life, and socioeconomic status over time. Laboratory tests and biomarker measurements will also be conducted to evaluate the intervention's efficacy.
Who should consider this trial
Good fit: Ideal candidates are daily smokers aged 18-80 who have been hospitalized for alcohol-induced acute pancreatitis.
Not a fit: Patients with acute pancreatitis caused by factors other than alcohol or those with severe psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the recurrence of acute pancreatitis in patients who consume alcohol and smoke.
How similar studies have performed: While there is clinical equipoise regarding the impact of alcohol and smoking cessation, this study aims to fill a gap in the literature, as well-designed clinical trials on this topic are lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pécs
- Institute for Translational Medicine, University of Pécs — Pécs, Hungary (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Pancreatitis, Recurrent Acute Pancreatitis, acute pancreatitis, recurrent acute pancreatitis, smoking, alcohol, lifestyle intervention