Idiopathic Recurrent Acute Pancreatitis (IRAP)

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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Key information

Conditions

Pancreatitis Digestive System Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aurora St. Lukes Medical Center of Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years or older
Able to provide consent
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)
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

Unable to give informed consent.
Definite evidence of biliary or alcoholic pancreatitis.
Clear evidence of hypertriglyceridemia-induced pancreatitis (triglycerides >1,000 mg/dl).
Post-ERCP pancreatitis, drug-induced pancreatitis, or any identifiable cause for pancreatitis.
History of pancreatic surgery.

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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.

Acronym: IRAP

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2014
First posted: May 31, 2010
Registry last updated: Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed