Idiopathic Recurrent Acute Pancreatitis (IRAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nalini Guda, MD, Aurora Health Care
ClinicalTrials.gov Identifier:
NCT01133535
First received: May 28, 2010
Last updated: June 24, 2014
Last verified: June 2014

May 28, 2010
June 24, 2014
June 2010
December 2013   (final data collection date for primary outcome measure)
IDIOPATHIC RECURRENT ACUTE PANCREATITIS (IRAP) [ Time Frame: The goal is to recruit 1000 subjects in 5 years. ] [ Designated as safety issue: No ]

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).

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Complete list of historical versions of study NCT01133535 on ClinicalTrials.gov Archive Site
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Idiopathic Recurrent Acute Pancreatitis (IRAP)
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.

The purpose of this study is to collect standardized data on the diagnosis and management of idiopathic (unknown cause) recurrent acute pancreatitis. The intent is to collect data for at least five years to obtain information regarding long-term outcomes and obtain comparative effectiveness data.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects with recurrent pancreatitis presenting to major centers for pancreatic disorders

Pancreatitis
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Pancreatitis, acute, recurrent
Patients with acute recurrent pancreatitis where the cause is unknown
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years or older
  2. Able to provide consent
  3. More than one documented episode of pancreatitis (>3 fold elevation of amylase and or lipase with abdominal pain or with body imaging consistent with pancreatitis: need two of the three)
  4. Subjects with abdominal pain and enzyme elevation which is <3 fold above normal or absence of imaging findings: these subjects who are undergoing endoscopic interventions but do not fit the "classic criteria" for pancreatitis will be included but the analysis of data of these subjects would be done separately.

Note: subjects with a diagnosis of pancreas divisum and or Sphincter of Oddi dysfunction diagnosed prior to or after entry into the study will be included in the study but their data will be analyzed separately because of the controversy regarding the association of these entities with pancreatitis.

Exclusion Criteria:

  1. Unable to give informed consent.
  2. Definite evidence of biliary or alcoholic pancreatitis.
  3. Clear evidence of hypertriglyceridemia-induced pancreatitis (triglycerides >1,000 mg/dl).
  4. Post-ERCP pancreatitis, drug-induced pancreatitis, or any identifiable cause for pancreatitis.
  5. History of pancreatic surgery.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01133535
AHC-001
Yes
Nalini Guda, MD, Aurora Health Care
Aurora Health Care
Not Provided
Principal Investigator: Nalini M Guda, MD Aurora Health Care
Aurora Health Care
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP