Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation

NCT04647097 | Recruiting DMC

• 1 other identifier: 40394-10/2020/EÜIG
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis; Recurrent Acute Pancreatitis

Keywords

acute pancreatitis; recurrent acute pancreatitis; smoking; alcohol; lifestyle intervention

Outcome Measures

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.)

  24 months

Secondary Outcomes (11)

• Recurrence of acute pancreatitis irrespective of etiology

  6, 18,24 months

• Recurrence of alcohol-induced AP

  24 months

• Likely pancreatitis

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

• Length of hospital stay

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

• Presentation to the emergency unit, hospital re-admission

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

Study Arms (2)

Standard intervention plus repeated intervention

ACTIVE COMPARATOR

Patients randomized to the standard intervention plus repeated intervention arm

Behavioral: Standard intervention plus repeated intervention

Standard intervention only

ACTIVE COMPARATOR

Patients randomized to the standard intervention only arm

Behavioral: Standard intervention only

Interventions

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 only

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.

Standard intervention plus repeated intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Institute for Translational Medicine, University of Pécs

Pécs, 7624, Hungary

RECRUITING

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Related Links

• Capacities HMoH. Az Emberi Erőforrások Minisztériuma egészségügyi szakmai irányelve a dohányzásról való leszokás támogatásáról. https://tudogyogyasz.hu2019.

MeSH Terms

Conditions

Pancreatitis; Smoking

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors of the outcomes will be blinded regarding allocation. The medical team providing the visits and treatment during hospitalization rwill not be aware of the allocation. Patients and the study nurse can not be blinded, due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs

Model Details: Randomized controlled trial and a cohort study

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 30, 2020
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)