Idiopathic Recurrent Acute Pancreatitis (IRAP)

NCT ID: NCT01133535

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatitis, acute, recurrent

Patients with acute recurrent pancreatitis where the cause is unknown

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nalini M Guda, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Aurora St. Lukes Medical Center of Aurora Health Care

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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AHC-001

Identifier Type: -

Identifier Source: org_study_id

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