Idiopathic Recurrent Acute Pancreatitis (IRAP) (IRAP)
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|ClinicalTrials.gov Identifier: NCT01133535|
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : June 26, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||The IRAP Registry is a Multi-center Prospective, Collaborative Database Designed to Create a National Registry That Collects Information Concerning Episodes of Idiopathic Recurrent Acute Pancreatitis From Major 'Pancreas' Centers. Intent is to do a Comparative Effectiveness Study of Interventions.|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||April 2014|
Pancreatitis, acute, recurrent
Patients with acute recurrent pancreatitis where the cause is unknown
- IDIOPATHIC RECURRENT ACUTE PANCREATITIS (IRAP) [ Time Frame: The goal is to recruit 1000 subjects in 5 years. ]
Expect 750 to be treated with ERCP Expect 250 to be treated with conservative treatment. Therefore, the smaller group was used for the sample size analysis.
Smallest difference in QOL for treatment is expected to be 10-20%. For smaller of two treatment groups (N=250), no effect would be 0 got better and 250 did not. If 10% of the subjects improved, 25 would get better and 225 would not. Result: Chi-square analysis yielded a highly significantly difference as follows. Chi-square= 24.253 with 1 degrees of freedom. (P = <0.001). Yates correction for continuity was used in calculating this test.An alternate analysis is that for no effect, 125 subjects would get better and 125 patients would not (random effects model).
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): NCT01133535
|United States, Wisconsin|
|Aurora St. Lukes Medical Center of Aurora Health Care|
|Milwaukee, Wisconsin, United States, 53215|
|Principal Investigator:||Nalini M Guda, MD||Aurora Health Care|