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Acute PancreatitisREAPPEARNCT04647097

Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation

A study testing Standard intervention only and Standard intervention plus repeated intervention in people with Acute Pancreatitis and Recurrent Acute Pancreatitis, run by University of Pecs at 1 site in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Standard intervention only and Standard intervention plus repeated intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
1 siteHungary
Study dates
1 Mar 2022to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hungary1 site, 1 recruiting

  • Institute for Translational Medicine, University of Pécs

    Pécs, 7624

    Péter Hegyi, MD,PhD, Dsc, +3672/536-246, hegyi2009@gmail.com

    Klementina Ocskay, MD, ocskay.klementina@gmail.com

    Recruiting

Other trials in Hungary

About this study

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

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.

Read the 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.

Being tested
Standard intervention only, Standard intervention plus repeated intervention
Keywords
acute pancreatitis, recurrent acute pancreatitis, smoking, alcohol, lifestyle intervention
Medical subject headings
Pancreatitis, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard intervention onlyBehavioural

    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.

  • Standard intervention plus repeated interventionBehavioural

    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.

Study groups in NCT04647097
Study groupRoleWhat they receive
Standard intervention plus repeated interventionActive comparatorPatients randomized to the standard intervention plus repeated intervention arm
Receives: Behavioral: Standard intervention plus repeated intervention
Standard intervention onlyActive comparatorPatients randomized to the standard intervention only arm
Receives: Behavioral: Standard intervention only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite endpoint of recurrence rate of AP and all cause mortality

    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.)

    Measured: 24 months

Secondary outcomes (11)

  1. Recurrence of acute pancreatitis irrespective of etiology

    Recurrence of acute pancreatitis irrespective of etiology given as cumulative incidence and as rate of event

    Measured: 6, 18,24 months

  2. Recurrence of alcohol-induced AP

    Recurrence of alcohol-induced AP given as rate of event

    Measured: 24 months

  3. Likely pancreatitis

    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

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  4. Length of hospital stay

    Length of hospital stay given in days due to recurrent pancreatitis and overall during follow-up

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  5. Presentation to the emergency unit, hospital re-admission

    Presentation to the emergency unit, hospital re-admission given as cumulative incidence

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  6. Development of chronic pancreatitis

    Development of chronic pancreatitis given as incidence within 2 years

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  7. Healthcare cost

    Healthcare cost from the perspective of the health insurance fund within 2 years

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  8. Quality adjusted life years

    Quality adjusted life years (QALY) within 2 year

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  9. Change of alcohol consumption given in gram per week

    Change of alcohol consumption compared to baseline given in gram per week based on patient reported data

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  10. Change of tobacco use given in pieces per day

    Change of tobacco use compared to the baseline given in pieces per day based on patient reported data

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

  11. Change of alcohol consumption

    Change of alcohol consumption compared to baseline estimated from biomarker levels

    Measured: 3, 6, 9, 12, 15, 18, 21, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2020
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial and a cohort study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04647097
Sponsor's protocol ID
40394-10/2020/EÜIG
Acronym
REAPPEAR
Status last verified
Apr 2023
First submitted
16 Nov 2020
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wadhwa V, Patwardhan S, Garg SK, Jobanputra Y, Lopez R, Sanaka MR. Health Care Utilization and Costs Associated With Acute Pancreatitis. Pancreas. 2017 Mar;46(3):410-415. doi: 10.1097/MPA.0000000000000755.

    PubMed 28099261

  • Szentesi A, Toth E, Balint E, Fanczal J, Madacsy T, Laczko D, Ignath I, Balazs A, Pallagi P, Maleth J, Rakonczay Z Jr, Kui B, Illes D, Marta K, Blasko A, Demcsak A, Parniczky A, Par G, Godi S, Mosztbacher D, Szucs A, Halasz A, Izbeki F, Farkas N, Hegyi P; Hungarian Pancreatic Study Group. Analysis of Research Activity in Gastroenterology: Pancreatitis Is in Real Danger. PLoS One. 2016 Oct 24;11(10):e0165244. doi: 10.1371/journal.pone.0165244. eCollection 2016.

    PubMed 27776171

  • Machicado JD, Yadav D. Epidemiology of Recurrent Acute and Chronic Pancreatitis: Similarities and Differences. Dig Dis Sci. 2017 Jul;62(7):1683-1691. doi: 10.1007/s10620-017-4510-5. Epub 2017 Mar 9.

    PubMed 28281168

  • Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

    PubMed 23896955

  • Guda NM, Muddana V, Whitcomb DC, Levy P, Garg P, Cote G, Uc A, Varadarajulu S, Vege SS, Chari ST, Forsmark CE, Yadav D, Reddy DN, Tenner S, Johnson CD, Akisik F, Saluja AK, Lerch MM, Mallery JS, Freeman ML. Recurrent Acute Pancreatitis: International State-of-the-Science Conference With Recommendations. Pancreas. 2018 Jul;47(6):653-666. doi: 10.1097/MPA.0000000000001053.

    PubMed 29894415

  • Yadav D, O'Connell M, Papachristou GI. Natural history following the first attack of acute pancreatitis. Am J Gastroenterol. 2012 Jul;107(7):1096-103. doi: 10.1038/ajg.2012.126. Epub 2012 May 22.

    PubMed 22613906

  • Cote GA, Yadav D, Abberbock JA, Whitcomb DC, Sherman S, Sandhu BS, Anderson MA, Lewis MD, Alkaade S, Singh VK, Baillie J, Banks PA, Conwell D, Guda NM, Muniraj T, Tang G, Brand R, Gelrud A, Amann ST, Forsmark CE, Wilcox MC, Slivka A, Gardner TB. Recurrent Acute Pancreatitis Significantly Reduces Quality of Life Even in the Absence of Overt Chronic Pancreatitis. Am J Gastroenterol. 2018 Jun;113(6):906-912. doi: 10.1038/s41395-018-0087-7. Epub 2018 Jun 5.

    PubMed 29867178

  • Mandalia A, Wamsteker EJ, DiMagno MJ. Recent advances in understanding and managing acute pancreatitis. F1000Res. 2018 Jun 28;7:F1000 Faculty Rev-959. doi: 10.12688/f1000research.14244.2. eCollection 2018.

    PubMed 30026919

  • Krishna SG, Kamboj AK, Hart PA, Hinton A, Conwell DL. The Changing Epidemiology of Acute Pancreatitis Hospitalizations: A Decade of Trends and the Impact of Chronic Pancreatitis. Pancreas. 2017 Apr;46(4):482-488. doi: 10.1097/MPA.0000000000000783.

    PubMed 28196021

  • Nikkola J, Raty S, Laukkarinen J, Seppanen H, Lappalainen-Lehto R, Jarvinen S, Nordback I, Sand J. Abstinence after first acute alcohol-associated pancreatitis protects against recurrent pancreatitis and minimizes the risk of pancreatic dysfunction. Alcohol Alcohol. 2013 Jul-Aug;48(4):483-6. doi: 10.1093/alcalc/agt019. Epub 2013 Mar 28.

    PubMed 23538610

  • Magnusdottir BA, Baldursdottir MB, Kalaitzakis E, Bjornsson ES. Risk factors for chronic and recurrent pancreatitis after first attack of acute pancreatitis. Scand J Gastroenterol. 2019 Jan;54(1):87-94. doi: 10.1080/00365521.2018.1550670. Epub 2019 Jan 31.

    PubMed 30700163

  • Nikkola J, Laukkarinen J, Lahtela J, Seppanen H, Jarvinen S, Nordback I, Sand J. The Long-term Prospective Follow-up of Pancreatic Function After the First Episode of Acute Alcoholic Pancreatitis: Recurrence Predisposes One to Pancreatic Dysfunction and Pancreatogenic Diabetes. J Clin Gastroenterol. 2017 Feb;51(2):183-190. doi: 10.1097/MCG.0000000000000564.

    PubMed 28060789

  • Nordback I, Pelli H, Lappalainen-Lehto R, Jarvinen S, Raty S, Sand J. The recurrence of acute alcohol-associated pancreatitis can be reduced: a randomized controlled trial. Gastroenterology. 2009 Mar;136(3):848-55. doi: 10.1053/j.gastro.2008.11.044. Epub 2008 Nov 27.

    PubMed 19162029

  • Lappalainen-Lehto R, Koistinen N, Aalto M, Huhtala H, Sand J, Nordback I, Seppa K. Goal-related outcome after acute alcohol-pancreatitis -- a two-year follow-up study. Addict Behav. 2013 Dec;38(12):2805-9. doi: 10.1016/j.addbeh.2013.07.008. Epub 2013 Jul 21.

    PubMed 24018221

  • Tolstrup JS, Kristiansen L, Becker U, Gronbaek M. Smoking and risk of acute and chronic pancreatitis among women and men: a population-based cohort study. Arch Intern Med. 2009 Mar 23;169(6):603-9. doi: 10.1001/archinternmed.2008.601.

    PubMed 19307524

Questions about this trial

What is this clinical trial studying?

A study testing Standard intervention only and Standard intervention plus repeated intervention in people with Acute Pancreatitis and Recurrent Acute Pancreatitis, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint of recurrence rate of AP and all cause mortality (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04647097, which also lists 70 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.

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