Decrease of Recurrent Pancreatitis

NCT00534534 | Completed

• 1 other identifier: R00126A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an important factor in the development of recurrent pancreatitis, it was hypothesized, that by attempting intensively to diminish the individual alcohol consumption the number of recurrent pancreatitis could be decreased. Two protocols will be compared: A) initial intervention against alcohol abuse and B) repeated interventions at 6 month intervals.

Conditions

Pancreatitis

Keywords

Pancreatitis; acute; alcoholic; recurrence; alcoholism; treatment; Acute alcoholic pancreatitis

Outcome Measures

Primary Outcomes (1)

• The number of recurrent pancreatitis during the study period

  2 years

Secondary Outcomes (1)

• Decrease of alcohol consumption

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. In addition, they also will undergo repeated similar interventions at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.

Behavioral: Repeated behavioural intervention without any drugs

Standard

NO INTERVENTION

All these patients will be advised, i.e. undergo behavioural intervention, against alcohol use in the standard fashion. No drugs will be used. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.

Interventions

Repeated behavioural intervention without any drugs BEHAVIORAL

All these patients will be advised, i.e. undergo "behavioural intervention", against alcohol use in the standard fashion as those in the standard group. No drugs will be used as part of the intervention. They also will undergo repeated interventions at outpatient visits at 6 mo intervals. They are re-examined at two years for alcohol consumption and for the number of recurrent pancreatitis during the two year period.

1

Eligibility Criteria

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

You may qualify if:

• Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital

You may not qualify if:

• Other etiologies of pancreatitis besides alcohol
• Uncertain diagnosis
• Recurrent disease
• Refusal

Sponsors & Collaborators

• Tampere University: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Pancreatitis; Recurrence; Alcoholism

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Isto H Nordback, M.D.

  Tampere University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 26, 2007
• Study Start: January 1, 2001
• Study Completion: April 1, 2007
• Last Updated: September 26, 2007

Record last verified: 2007-09

Locations

FI (1)