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Pancreatic Exocrine Insufficiency in Acute Pancreatitis (APPEI)

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ClinicalTrials.gov Identifier: NCT02563080
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Leena Kylanpaa, Helsinki University Central Hospital

Brief 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 pancreatitis.

Condition or disease
Exocrine Pancreatic Insufficiency 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort
First attack of acute pancreatitis
50 patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis [ Time Frame: One year after discharging from hospital ]
    fecal elastase-1 <200 ug/g

  2. 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 ]
    fecal elastase-1 <200 ug/g


Other Outcome Measures:
  1. 30-day and hospital mortality after first attack of acute pancreatitis [ Time Frame: 30 days, hospitalization time ]
    mortality

  2. 5-year survival after first attack of acute pancreatitis [ Time Frame: 5 years ]
    survival


Biospecimen Retention:   None Retained
Fecal samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563080


Contacts
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Contact: Outi Lindström, MD,PhD +358504270574 outi.lindstrom@hus.fi
Contact: Leena Kylänpää, MD,PhD +358504272869 leena.kylanpaa@hus.fi

Locations
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Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Outi Lindström, MD,PhD    +358504270574    outi.lindstrom@hus.fi   
Contact: Leena Kylänpää, MD,PhD    +358504272869    leena.kylanpaa@hus.fi   
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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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
Additional Information:

Publications:
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Responsible Party: Leena Kylanpaa, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02563080    
Other Study ID Numbers: Exocrine insufficiency
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Leena Kylanpaa, Helsinki University Central Hospital:
exocrine insufficiency
acute pancreatitis
severe
moderately severe
Additional relevant MeSH terms:
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Pancreatitis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases