Pancreatic Exocrine Insufficiency in Acute Pancreatitis
Condition: Exocrine Pancreatic Insufficiency; Acute Pancreatitis
MeSH terms: Pancreatitis; Exocrine Pancreatic Insufficiency
Study type: Observational [Patient Registry]

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.
    

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.
      
Biospecimen description: 
      Fecal samples.
    
Keywords: exocrine insufficiency; acute pancreatitis; severe; moderately severe