Clinical trial NCT02563080: Pancreatic Exocrine Insufficiency in Acute Pancreatitis
Official title: Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exocrine Pancreatic Insufficiency
Acute Pancreatitis
Keywords: exocrine insufficiency
acute pancreatitis
severe
moderately severe
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University 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.

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.

Eligibility 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

Primary outcomes:
measure: Development of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis confirmed by fecal elastase-1 test.
timeFrame: One year after discharging from hospital
Secondary outcomes:
measure: Persistence of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis
timeFrame: One year after discharging from hospital
measure: New developments of pancreatic exocrine insufficiency after first attack of moderately severe or severe acute pancreatitis during the follow-up time
timeFrame: One year after discharging from hospital
Other outcomes:
measure: 30-day and hospital mortality after first attack of acute pancreatitis
timeFrame: 30 days, hospitalization time
measure: 5-year survival after first attack of acute pancreatitis
timeFrame: 5 years
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Leena Kylänpää, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Outi Lindström, Md,PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Taija Korpela, MD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Marianne Udd, MD,PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Panu Mentula, MD,PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Päivi Siironen, MD,PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Matti Tolonen, MD
role: STUDY_CHAIR
affiliation: Turku University Hospital
name: Elina Lietzen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.