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Decrease of Recurrent Pancreatitis

Primary Purpose

Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Repeated behavioural intervention without any drugs
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Pancreatitis, acute, alcoholic, recurrence, alcoholism, treatment, Acute alcoholic pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

Standard

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The number of recurrent pancreatitis during the study period

Secondary Outcome Measures

Decrease of alcohol consumption

Full Information

First Posted
September 21, 2007
Last Updated
September 24, 2007
Sponsor
Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT00534534
Brief Title
Decrease of Recurrent Pancreatitis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tampere University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Pancreatitis, acute, alcoholic, recurrence, alcoholism, treatment, Acute alcoholic pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Repeated behavioural intervention without any drugs
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of recurrent pancreatitis during the study period
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Decrease of alcohol consumption
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isto H Nordback, M.D.
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

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Decrease of Recurrent Pancreatitis

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