No registrations found.
ID
Source
Brief title
Health condition
Acute alcoholic pancreatitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrent acute alcoholic pancreatitis
Secondary outcome
Cessation of alcohol use (defined as a modified AUDIT score of 0 at any time point during follow-up), clinically relevant reduction of alcohol use (defined as a modified AUDIT score ranging between 1 and 7 at any time point during follow-up), clinically relevant reduction of alcohol dependence (defined as a Short Alcohol Dependence Data (SADD) score between 1 and 9 at any time during follow-up), development of chronic pancreatitis, development of alcohol-related disease (liver steatosis, liver cirrhosis), mortality, quality of life, costs
Background summary
Rationale: The most important risk factor for pancreatitis recurrence and chronic pancreatitis in acute alcoholic pancreatitis is continuation of alcohol use, yet no cessation support program is applied in current practice.
Objective: To determine whether an optimally timed personalized multidisciplinary alcohol cessation support program can reduce pancreatitis recurrence in acute alcoholic pancreatitis as compared to standard practice.
Study design: Nationwide cluster randomized superiority trial. Participating centers will be randomized for the investigational management or standard practice in an equal allocation ratio and stratification according to hospital type (academic vs. non-academic).
Study population: Patients with a first episode of acute alcoholic pancreatitis (defined as an Alcohol Use Disorders Identification Test [AUDIT] score >7) without indication for referral to an addiction specialized physician (i.e. AUDIT > 15) will be included.
Intervention: The investigational management is based on the evidence-based general practice guideline on problematic alcohol use and consists of a program with six steps during hospital admission and after discharge, in which patients with acute alcoholic pancreatitis are individually supported in their alcohol cessation attempt.
Comparison: Care for acute alcoholic pancreatitis patients according to current practice.
Endpoints: The primary outcome is alcoholic pancreatitis recurrence. Secondary outcomes include cessation or reduction of alcohol use, development of chronic pancreatitis and quality of life. The follow-up period will comprise one year after admission.
Study objective
Implementation of an alcohol cessation support program reduces recurrence of acute alcoholic pancreatitis in patients with a first episode of acute alcoholic pancreatitis
Study design
Expected start data: December 2020
Inclusion period: 2 years
Follow-up period: 1 year after inclusion
Expected end date: December 2023
Intervention
The intestigational management is based on the evidence-based general practice guideline on problematic alcohol use and consists of a program with six steps during hospital admission and after discharge, in which patients with acute alcoholic pancreatitis are individually supported in their alcohol cessation attempt
Inclusion criteria
First episode of acute pancreatitis (according to the Revised Atlanta criteria), harmfull drinking (defined as AUDIT score>7), age of 18 or older and provided written informed consent
Exclusion criteria
Chronic pancreatitis, indication for referral to an addiction specialized phsyician (AUDIT>15), diagnosis of any etiology other than alcoholic after standard diagnostic work-up according to the IAP/APA evidence-based guidelines
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8852 |
| Other | Medical research Ethics Committees United (MEC-U) : W20.172 |