Exocrine Pancreatic InsufficiencyAPPEINCT02563080
Pancreatic Exocrine Insufficiency in Acute Pancreatitis
An observational study of Exocrine Pancreatic Insufficiency and Acute Pancreatitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Severe pancreatitis induces more damage in the pancreas and might therefore result reduced exocrine function leading to the insufficiency. The aim of this prospective study is to investigate development of pancreatic exocrine insufficiency in patients recovering from first attack of moderately severe or severe acute… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Acute Pancreatitis
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2015to Feb 2022
- How long will I take part?
- 5 Years
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.
Who may be able to join
- 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
Who cannot join
- previous history of acute pancreatitis
- chronic pancreatitis
- known pancreatic exocrine insufficiency
- previous pancreatic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis
Severe pancreatitis induces more damage in the pancreas and might therefore result reduced exocrine function leading to the insufficiency. The aim of this prospective study is to investigate development of pancreatic exocrine insufficiency in patients recovering from first attack of moderately severe or severe acute pancreatitis.
Read the 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.
- Keywords
- exocrine insufficiency, acute pancreatitis, severe, moderately severe
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatitis, Lymphoma, Follicular
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 |
|---|---|---|
| First attack of acute pancreatitis | 50 patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis confirmed by fecal elastase-1 test.
fecal elastase-1 <200 ug/g
Measured: One year after discharging from hospital
Secondary outcomes (2)
Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis
fecal elastase-1 <200 ug/g
Measured: One year after discharging from hospital
New developments of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis during the follow-up time
fecal elastase-1 <200 ug/g
Measured: One year after discharging from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2022
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leena Kylanpaa, Helsinki University Central Hospital
- Investigators
- Leena Kylänpää, MD,PhD, Principal investigator, Helsinki University Central HospitalOuti Lindström, Md,PhD, Study chair, Helsinki University Central HospitalTaija Korpela, MD, Study chair, Helsinki University Central HospitalMarianne Udd, MD,PhD, Study chair, Helsinki University Central HospitalPanu Mentula, MD,PhD, Study chair, Helsinki University Central HospitalPäivi Siironen, MD,PhD, Study chair, Helsinki University Central HospitalMatti Tolonen, MD, Study chair, Helsinki University Central HospitalElina Lietzen, MD, Study chair, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563080
- Sponsor's protocol ID
- Exocrine insufficiency
- Acronym
- APPEI
- Status last verified
- Aug 2022
- First submitted
- 27 Sep 2015
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23100216Boreham 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.
PubMed 12890992Lindstrom O, Lietzen E, Mentula P, Tolonen M, Siironen P, Udd M, Puolakkainen P, Kylanpaa L. Development of pancreatic exocrine insufficiency after first moderately severe or severe acute pancreatitis. Scand J Gastroenterol. 2025 Sep;60(9):921-927. doi: 10.1080/00365521.2025.2533337. Epub 2025 Jul 17.
PubMed 40673865
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT02563080
- Acronym / sponsor ID
- APPEI / Exocrine insufficiency
- Keywords
- exocrine insufficiency, acute pancreatitis, severe, moderately severe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 29 Sep 2015 (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.
Severe pancreatitis induces more damage in the pancreas and might therefore result reduced exocrine function leading to the insufficiency. The aim of this prospective study is to investigate development of pancreatic exocrine insufficiency in patients recovering from first attack of moderately severe or severe acute pancreatitis.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First attack of acute pancreatitis | – | –50 patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- previous history of acute pancreatitis
- chronic pancreatitis
- known pancreatic exocrine insufficiency
- previous 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
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
fecal elastase-1 <200 ug/g
2 secondary outcomes
Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis
Time frame: One year after discharging from hospital
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
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 16 Aug 2022.
- Background: PubMed 23100216Banks 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.
- Background: PubMed 12890992Boreham 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.
- Derived from this study: PubMed 40673865Lindstrom O, Lietzen E, Mentula P, Tolonen M, Siironen P, Udd M, Puolakkainen P, Kylanpaa L. Development of pancreatic exocrine insufficiency after first moderately severe or severe acute pancreatitis. Scand J Gastroenterol. 2025 Sep;60(9):921-927. doi: 10.1080/00365521.2025.2533337. Epub 2025 Jul 17.
- Individual participant dataSharing planned: No
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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.
Leena Kylänpää, MD,PhD principal investigator
Helsinki University Central Hospital
Outi Lindström, Md,PhD study chair
Helsinki University Central Hospital
Taija Korpela, MD study chair
Helsinki University Central Hospital
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 Exocrine Pancreatic Insufficiency and Acute Pancreatitis, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 inclusion and 4 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 16 Aug 2022. 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 Finland. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563080, which also lists 3 linked publications.
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 16 Aug 2022.