Idiopathic Recurrent Acute Pancreatitis (IRAP)

NCT01133535 | Completed DMC

• 1 other identifier: AHC-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Pancreatitis, acute, recurrent

Patients with acute recurrent pancreatitis where the cause is unknown

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with recurrent pancreatitis presenting to major centers for pancreatic disorders

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora St. Lukes Medical Center of Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Nalini M Guda, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: May 31, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 3, 2024

Record last verified: 2014-06

Locations

US (1)