- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02563080
Pancreatic Exocrine Insufficiency in Acute Pancreatitis (APPEI)
Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis
Study Overview
Status
Detailed Description
This is a prospective pilot study of 50 patients with first attack of moderately severe or severe acute pancreatitis (AP) classified by the new revised criteria for AP 2012 treated in Helsinki University Hospital. The included patients are treated according to the existing hospital practice and current guidelines for AP (American Pancreatic Association guidelines). The development of pancreatic exocrine insufficiency is determined by measuring the fecal elastase-1 test. The test is measured during the hospitalization time (baseline testing), and in the follow-up period 1-2 months and 12 months after discharging from hospital. The baseline test will be measured as soon as the severity of AP is known and patient is included in the study, and the first stool sample is available. Patients with previous history of AP, chronic pancreatitis, known pancreatic exocrine insufficiency or previous pancreatic surgery will be excluded.
The patients' characteristics (age, gender, comorbidities) and etiology of AP, laboratory values on admission, imaging findings and data of given treatments and interventional therapies and length of hospital stays are collected from hospital charts. Also the 30-day and hospital mortality will be recorded. Patients' symptoms (weight loss, diarrhea, abdominal pain) and BMIs are recorded with physical examinations in the 1-2 months follow-up visit. 12 months after discharging from hospital the patients' symptoms and BMIs are recorded with phone inquiries. 5-year survival after the first AP attack will be determined from hospital records.
The approval of the ethics committee of the hospital has been obtained. An informed consent will be obtained from all patients.
Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe AP confirmed by fecal elastase-1 test is the primary endpoint of this study. Also, the persistence pancreatic exocrine insufficiency and probable new developments of it during the follow-up will be assessed (secondary endpoints). 30-day and hospital mortality and 5-year survival after first attack of moderately severe or severe AP will be determined as well (secondary endpoints).
The aim in this study (during the study period) is not to change the existing management of AP. The existing guidelines for treatment of severe AP patients do not include enzyme supplementation therapy. However, if the patients have low fecal elastase-1 levels indicating pancreatic exocrine insufficiency after the follow-up period of 12 months, they will be informed about the enzyme supplementation therapy. And if the patients are willing to start the therapy, it can be administrated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Helsinki, Finland, 00029
- Helsinki University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- first episode of acute pancreatitis (diagnosis based on acute onset of characteristic symptoms and elevated plasma levels of amylase and/or typical findings on CT)
- severity of acute pancreatitis classified as moderately severe or severe by revised Atlanta classification of acute pancreatitis 2012
Exclusion Criteria:
- previous history of acute pancreatitis
- chronic pancreatitis
- known pancreatic exocrine insufficiency
- previous pancreatic surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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First attack of acute pancreatitis
50 patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis confirmed by fecal elastase-1 test.
Time Frame: One year after discharging from hospital
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fecal elastase-1 <200 ug/g
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One year after discharging from hospital
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis
Time Frame: One year after discharging from hospital
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fecal elastase-1 <200 ug/g
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One year after discharging from hospital
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New developments of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis during the follow-up time
Time Frame: One year after discharging from hospital
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fecal elastase-1 <200 ug/g
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One year after discharging from hospital
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day and hospital mortality after first attack of acute pancreatitis
Time Frame: 30 days, hospitalization time
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mortality
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30 days, hospitalization time
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5-year survival after first attack of acute pancreatitis
Time Frame: 5 years
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survival
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5 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Leena Kylänpää, MD,PhD, Helsinki University Central Hospital
- Study Chair: Outi Lindström, Md,PhD, Helsinki University Central Hospital
- Study Chair: Taija Korpela, MD, Helsinki University Central Hospital
- Study Chair: Marianne Udd, MD,PhD, Helsinki University Central Hospital
- Study Chair: Panu Mentula, MD,PhD, Helsinki University Central Hospital
- Study Chair: Päivi Siironen, MD,PhD, Helsinki University Central Hospital
- Study Chair: Matti Tolonen, MD, Helsinki University Central Hospital
- Study Chair: Elina Lietzen, MD, Turku University Hospital
Publications and helpful links
General Publications
- Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Boreham B, Ammori BJ. A prospective evaluation of pancreatic exocrine function in patients with acute pancreatitis: correlation with extent of necrosis and pancreatic endocrine insufficiency. Pancreatology. 2003;3(4):303-8. doi: 10.1159/000071768.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Exocrine insufficiency
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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