PancreatitisIRAPNCT01133535
Idiopathic Recurrent Acute Pancreatitis (IRAP)
An observational study of Pancreatitis, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with recurrent pancreatitis presenting to major centers for pancreatic disorders
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora St. Lukes Medical Center of Aurora Health Care
Milwaukee, Wisconsin, 53215
About this study
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.
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
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatitis, acute, recurrent | Patients with acute recurrent pancreatitis where the cause is unknown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The goal is to recruit 1000 subjects in 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nalini M Guda, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133535
- Sponsor's protocol ID
- AHC-001
- Acronym
- IRAP
- Status last verified
- Jun 2014
- First submitted
- 28 May 2010
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01133535
- Acronym / sponsor ID
- IRAP / AHC-001
- Conditions
- Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatitis, acute, recurrent | – | –Patients with acute recurrent pancreatitis where the cause is unknown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with recurrent pancreatitis presenting to major centers for pancreatic disorders
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nalini M Guda, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IDIOPATHIC RECURRENT ACUTE PANCREATITIS (IRAP) (time frame: The goal is to recruit 1000 subjects in 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.