Decrease of Recurrent Pancreatitis

Pancreatitis Clinical Trial

Official title:

Randomized Clinical Trial of the Effect of Standard Versus Intensive Intervention Protocol in Attempting to Reduce Recurrent Episodes of Acute Alcoholic Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534534
• Other study ID #: R00126A
• Status: Completed
• Phase: N/A
• First received: September 21, 2007
• Last updated: September 24, 2007
• Start date: January 2001
• Est. completion date: April 2007

Study information

• Verified date: September 2007
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis

Intervention

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.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of recurrent pancreatitis during the study period		2 years
Secondary	Decrease of alcohol consumption		2 years