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.

Population

Patients with first attack of moderately severe or severe acute pancreatitis treated in Helsinki University Hospital.

Brief Title

Pancreatic Exocrine Insufficiency in Acute Pancreatitis

Official Title

Development of Pancreatic Exocrine Insufficiency After Moderately Severe or Severe Acute Pancreatitis

Brief Summary

Severe pancreatitis induces more damage in the pancreas and might therefore result reduced <br /> exocrine function leading to the insufficiency. The aim of this prospective study is to <br /> investigate development of pancreatic exocrine insufficiency in patients recovering from <br /> 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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