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Decrease of Recurrent Pancreatitis

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ClinicalTrials.gov Identifier: NCT00534534
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Sponsor:
Information provided by:
University of Tampere

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.

Condition or disease Intervention/treatment Phase
Pancreatitis Behavioral: Repeated behavioural intervention without any drugs Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2001
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. The number of recurrent pancreatitis during the study period [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Decrease of alcohol consumption [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00534534     History of Changes
Other Study ID Numbers: R00126A
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007

Keywords provided by University of Tampere:
Pancreatitis
acute
alcoholic
recurrence
alcoholism
treatment
Acute alcoholic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Alcoholic
Pancreatic Diseases
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders