Decrease of Recurrent Pancreatitis

This study has been completed.

Sponsor:

Information provided by:

University of Tampere

ClinicalTrials.gov Identifier:

NCT00534534

First received: September 21, 2007

Last updated: September 24, 2007

Last verified: September 2007

History of Changes

Purpose

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.

Condition	Intervention
Pancreatitis	Behavioral: Repeated behavioural intervention without any drugs

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Clinical Trial of the Effect of Standard Versus Intensive Intervention Protocol in Attempting to Reduce Recurrent Episodes of Acute Alcoholic Pancreatitis

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Alcohol Pancreatitis

U.S. FDA Resources

Further study details as provided by University of Tampere:

Primary Outcome Measures:

The number of recurrent pancreatitis during the study period [ Time Frame: 2 years ]

Secondary Outcome Measures:

Decrease of alcohol consumption [ Time Frame: 2 years ]

Estimated Enrollment:	120
Study Start Date:	January 2001
Study Completion Date:	April 2007

Arms	Assigned Interventions
Active Comparator: 1 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 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.
No Intervention: Standard 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.

Arms

Assigned Interventions

Active Comparator: 1

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

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.

No Intervention: Standard

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Other etiologies of pancreatitis besides alcohol
Uncertain diagnosis
Recurrent disease
Refusal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534534

Locations

Finland
Tampere University Hospital
Tampere, Finland, 33521

Sponsors and Collaborators

University of Tampere

Investigators

Study Chair:

Isto H Nordback, M.D.

Tampere University Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00534534 History of Changes
Other Study ID Numbers:	R00126A
Study First Received:	September 21, 2007
Last Updated:	September 24, 2007
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by University of Tampere:

Pancreatitis
acute
alcoholic
recurrence

alcoholism
treatment
Acute alcoholic pancreatitis

Additional relevant MeSH terms:

Pancreatitis
Pancreatitis, Chronic
Pancreatitis, Alcoholic
Pancreatic Diseases

Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 23, 2013

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