CompletedNot Applicable

Idiopathic Recurrent Acute Pancreatitis (IRAP)

United States50 participantsStarted 2010-06

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

IDIOPATHIC RECURRENT ACUTE PANCREATITIS (IRAP)

Timeframe: The goal is to recruit 1000 subjects in 5 years.

Trial details

NCT IDNCT01133535

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Pancreatitis trials