Idiopathic Recurrent Acute Pancreatitis (IRAP) (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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Lukes Medical Center of Aurora Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with recurrent pancreatitis presenting to major centers for pancreatic disorders

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pancreatitis, acute, recurrent; Patients with acute recurrent pancreatitis where the cause is unknown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IDIOPATHIC RECURRENT ACUTE PANCREATITIS (IRAP)	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).	The goal is to recruit 1000 subjects in 5 years.

Collaborators and Investigators

• Sponsor: Aurora Health Care
• Investigators: Principal Investigator: Nalini M Guda, MD, Aurora Health Care

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: AHC-001