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

April 25, 2023 updated by: Dr Hegyi Péter, University of Pecs

Recurrent Acute Pancreatitis Prevention by the Elimination of Alcohol and Cigarette Smoking (REAPPEAR): Protocol of a Randomized Controlled Trial and a Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard intervention plus repeated intervention
Patients randomized to the standard intervention plus repeated intervention arm
Behavioral: Standard intervention plus repeated intervention
Standard intervention (SI) will be performed as described above. The repeated intervention will be delivered by the former mentioned same nurse and will be structured similarly to the standard intervention. Every visit and intervention will be individually altered according to the motivation of the patient, but they will follow the same structure. The sessions can be divided into three main parts: first, highlighting the harmful effects of smoking and alcohol on the pancreatic functions. Secondly, a discussion about the motivation of the patient will happen. The last portion of the session will focus on the responsibility of the individual to reach the desired goal will be highlighted. To enhance the efficacy of our intervention we wish to provide feed-back for the patient based on laboratory testing: the mean corpuscular volume (MCV) and gamma glutamyl-transferase (GGT) values will be measured right before the interview. The study nurse will not take part in patient care.
Active Comparator: Standard intervention only
Patients randomized to the standard intervention only arm
Behavioral: Standard intervention only
Standard intervention (SI) will be a part of standard care in all participating centers, and will be provided for all acute pancreatitis patients, who are hospitalized and their condition is alcohol induced. A specially trained study nurse will deliver the intervention, since they were found to be the most effective regarding the decrease in alcohol consumption and smoking. The cost- effectiveness of the intervention and the feasibility were also taken into account. The Assist-linked brief intervention according to the World Health Organization (WHO) will serve as the base for the intervention, with an avarage of 30 minutes, based on a review containing 69 randomized controlled trials, which concluded that longer intervention do not have additional benefit. The patients will be also educated about the disease course of acute pancreatitis during the standard intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of recurrence rate of AP and all cause mortality
Time Frame: 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.)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of acute pancreatitis irrespective of etiology
Time Frame: 6, 18,24 months
Recurrence of acute pancreatitis irrespective of etiology given as cumulative incidence and as rate of event
6, 18,24 months
Recurrence of alcohol-induced AP
Time Frame: 24 months
Recurrence of alcohol-induced AP given as rate of event
24 months
Likely pancreatitis
Time Frame: 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
3, 6, 9, 12, 15, 18, 21, 24 months
Length of hospital stay
Time Frame: 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
3, 6, 9, 12, 15, 18, 21, 24 months
Presentation to the emergency unit, hospital re-admission
Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months
Presentation to the emergency unit, hospital re-admission given as cumulative incidence
3, 6, 9, 12, 15, 18, 21, 24 months
Development of chronic pancreatitis
Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months
Development of chronic pancreatitis given as incidence within 2 years
3, 6, 9, 12, 15, 18, 21, 24 months
Healthcare cost
Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months
Healthcare cost from the perspective of the health insurance fund within 2 years
3, 6, 9, 12, 15, 18, 21, 24 months
Quality adjusted life years
Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months
Quality adjusted life years (QALY) within 2 year
3, 6, 9, 12, 15, 18, 21, 24 months
Change of alcohol consumption given in gram per week
Time Frame: 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
3, 6, 9, 12, 15, 18, 21, 24 months
Change of tobacco use given in pieces per day
Time Frame: 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
3, 6, 9, 12, 15, 18, 21, 24 months
Change of alcohol consumption
Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 months
Change of alcohol consumption compared to baseline estimated from biomarker levels
3, 6, 9, 12, 15, 18, 21, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

December 31, 2027

Study Completion (Anticipated)

June 30, 2028

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 21, 2020

First Posted (Actual)

November 30, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40394-10/2020/EÜIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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