Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation

Not Applicable

Recruiting

• Conditions: Acute Pancreatitis; Recurrent Acute Pancreatitis
• Interventions: Behavioral: Standard intervention only; Behavioral: Standard intervention plus repeated intervention

• Registration Number: NCT04647097
• Lead Sponsor: University of Pecs

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.

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-21
• Study First Posted: 2020-11-30
• Study Start: 2022-03-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard intervention only	Standard intervention only	Patients randomized to the standard intervention only arm
Standard intervention plus repeated intervention	Standard intervention plus repeated intervention	Patients randomized to the standard intervention plus repeated intervention arm

Primary Outcome Measures

Name	Time	Method
Composite endpoint of recurrence rate of AP and all cause mortality	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.)

Secondary Outcome Measures

Name	Time	Method
Healthcare cost	3, 6, 9, 12, 15, 18, 21, 24 months	Healthcare cost from the perspective of the health insurance fund within 2 years
Length of hospital stay	3, 6, 9, 12, 15, 18, 21, 24 months	Length of hospital stay given in days due to recurrent pancreatitis and overall during follow-up
Development of chronic pancreatitis	3, 6, 9, 12, 15, 18, 21, 24 months	Development of chronic pancreatitis given as incidence within 2 years
Recurrence of acute pancreatitis irrespective of etiology	6, 18,24 months	Recurrence of acute pancreatitis irrespective of etiology given as cumulative incidence and as rate of event
Recurrence of alcohol-induced AP	24 months	Recurrence of alcohol-induced AP given as rate of event
Likely pancreatitis	3, 6, 9, 12, 15, 18, 21, 24 months	Likely pancreatitis, fulfilling the diagnostic criteria of epigastric pain, a serum amylase or lipase level at least two times the upper normal level, and elevated leukocyte count or CRP levels
Quality adjusted life years	3, 6, 9, 12, 15, 18, 21, 24 months	Quality adjusted life years (QALY) within 2 year
Change of alcohol consumption given in gram per week	3, 6, 9, 12, 15, 18, 21, 24 months	Change of alcohol consumption compared to baseline given in gram per week based on patient reported data
Change of alcohol consumption	3, 6, 9, 12, 15, 18, 21, 24 months	Change of alcohol consumption compared to baseline estimated from biomarker levels
Presentation to the emergency unit, hospital re-admission	3, 6, 9, 12, 15, 18, 21, 24 months	Presentation to the emergency unit, hospital re-admission given as cumulative incidence
Change of tobacco use given in pieces per day	3, 6, 9, 12, 15, 18, 21, 24 months	Change of tobacco use compared to the baseline given in pieces per day based on patient reported data

Trial Locations

Locations (1)

Institute for Translational Medicine, University of Pécs; 🇭🇺 Pécs, Hungary