Health TrialsbyHealthPanel

Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation

ConditionsAcute PancreatitisRecurrent Acute Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Pecs

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard intervention only

    Behavioral

    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 intervention

    Behavioral

    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.

Treatment groups

364 Participants
are divided into 2 treatment groups
Group A: Standard intervention plus repeated interventionActive comparator 1 intervention
Group B: Standard intervention onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.)

Time frame
24 months

Secondary outcomes

1

Recurrence of acute pancreatitis irrespective of etiology

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

Time frame
6, 18,24 months
2

Recurrence of alcohol-induced AP

Recurrence of alcohol-induced AP given as rate of event

Time frame
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

Time frame
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

Time frame
3, 6, 9, 12, 15, 18, 21, 24 months

Other outcomes

Sponsors and contacts

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University of Pecs

Lead sponsor

Source ClinicalTrials.gov
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