Idiopathic Recurrent Acute Pancreatitis (IRAP)

Pancreatitis Clinical Trial

— IRAP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133535
• Other study ID #: AHC-001
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: June 24, 2014
• Start date: June 2010
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatitis

Locations

Country	Name	City	State
United States	Aurora St. Lukes Medical Center of Aurora Health Care	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No