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
  Purpose

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.


Condition
Pancreatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Aurora Health Care:

Primary Outcome Measures:
  • 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).



Enrollment: 50
Study Start Date: June 2010
Study Completion Date: April 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pancreatitis, acute, recurrent
Patients with acute recurrent pancreatitis where the cause is unknown

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with recurrent pancreatitis presenting to major centers for pancreatic disorders

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133535

Locations
United States, Wisconsin
Aurora St. Lukes Medical Center of Aurora Health Care
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Aurora Health Care
Investigators
Principal Investigator: Nalini M Guda, MD Aurora Health Care
  More Information

No publications provided

Responsible Party: Nalini Guda, MD, Research Regulatory Specialist, Aurora Health Care
ClinicalTrials.gov Identifier: NCT01133535     History of Changes
Other Study ID Numbers: AHC-001
Study First Received: May 28, 2010
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014