Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04647097

Recurrent Acute Pancreatitis Prevention by Eliminating Alcohol and Cigarette Smoking: A Randomized Controlled Trial and Cohort Study

Led by University of Pecs · Updated on 2023-04-26

364

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether stopping alcohol consumption and smoking can prevent the recurrence of acute pancreatitis, a condition often worsened by these habits. This combined study includes a randomized controlled trial and a cohort study to assess the effectiveness of lifestyle changes in reducing repeated episodes of acute pancreatitis and related health outcomes. The study focuses on patients who are daily smokers hospitalized with alcohol-induced pancreatitis and aims to clarify the impact of quitting alcohol and tobacco. Participants will receive either a standard intervention or a standard intervention plus repeated intervention. The standard intervention involves a 30-minute counseling session based on WHO guidelines, delivered by trained nurses, including education about acute pancreatitis. The repeated intervention adds ongoing personalized counseling every three months, with feedback based on laboratory tests like mean corpuscular volume and gamma glutamyl-transferase to support motivation. The study monitors participants over two years to evaluate recurrence rates and mortality. During the study, patients will attend visits every three months or yearly depending on their assigned group. At each visit, researchers will assess addiction, motivation, quality of life, and socioeconomic status, and collect laboratory samples including blood, urine, and hair for biomarker analysis. Outcomes measured include recurrence of pancreatitis, hospital visits, development of chronic pancreatitis, healthcare costs, and alcohol and tobacco use changes. The study also evaluates cost-effectiveness and monitors safety throughout the 24-month period.

CONDITIONS

Brief Title

Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient hospitalized with alcohol-induced acute pancreatitis as defined by the revised Atlanta criteria
  • Daily smoker with at least 1 year of smoking history, having smoked at least 100 cigarettes in lifetime
  • Age between 18 and 80 years
  • Provided written informed consent
  • Willing to participate in intervention visits every three months
Not Eligible

You will not qualify if you...

  • Acute pancreatitis caused by other factors than alcohol that cannot be resolved during initial hospital stay
  • Untreated or severe major psychiatric illnesses such as schizophrenia, bipolar disorder, or dementia
  • Currently participating in a smoking cessation program
  • Receiving active or palliative cancer treatment
  • Pregnancy or breastfeeding
  • Life expectancy less than two years
  • Declined to participate
  • Other unspecified exclusion reasons

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 months

Participants receive a standard intervention to support cessation of alcohol and smoking. Those in the repeated intervention arm receive additional tailored sessions every 3 months with feedback based on laboratory testing.

Visits every 3 months or yearly depending on random allocation

Follow-up

Duration - Up to 24 months

Participants are monitored for recurrence of acute pancreatitis, changes in alcohol and tobacco use, quality of life, and healthcare outcomes for up to 24 months.

Assessments at 3, 6, 9, 12, 15, 18, 21, and 24 months

Trial Site Locations

Total: 1 location

1

Institute for Translational Medicine, University of Pécs

Pécs, Hungary, 7624

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Recurrent Acute Pancreatitis Significantly Reduces Quality of Life Even in the Absence of Overt Chronic Pancreatitis.

Gregory A Coté, Dhiraj Yadav, Judah A Abberbock...

https://pubmed.ncbi.nlm.nih.gov/29867178

The Changing Epidemiology of Acute Pancreatitis Hospitalizations: A Decade of Trends and the Impact of Chronic Pancreatitis.

Somashekar G Krishna, Amrit K Kamboj, Phil A Hart...

https://pubmed.ncbi.nlm.nih.gov/28196021

Abstinence after first acute alcohol-associated pancreatitis protects against recurrent pancreatitis and minimizes the risk of pancreatic dysfunction.

Jussi Nikkola, Sari Räty, Johanna Laukkarinen...

https://pubmed.ncbi.nlm.nih.gov/23538610