Enzyme Suppletion in Exocrine Pancreatic Dysfunction
Condition: Chronic Pancreatitis; Exocrine Pancreatic Insufficiency
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according
      to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the
      treatment to be effective. In addition, consultation of a specialized dietician is pivotal to
      educate patients about the proper use of pancreatic enzymes. However, based on a recent
      prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that
      enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess
      if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after
      extensive patient-education in comparison to the standard treatment for patients with EPI.
    

Detailed description: 
      This is a prospective, open, comparative study with a linear design with two sequential
      phases (observatory, then patient-monitored).

      The research population consists of patients who are treated with pancreatic enzymes (< 6
      capsules p/d containing 25,000 units of lipase) for exocrine insufficiency caused by chronic
      pancreatitis.

      After inclusion, patients will discontinue taking pancreatic enzymes during one week
      (wash-out period). The last four days of this week, a fecal fat balance test will be
      performed to quantify the fecal fat loss without enzyme correction. If the fecal fat
      excretion is less than 15%, this is considered normal and therefore the patient will be
      excluded from the study. Subsequently, the next three weeks of the trial the patient will
      restart using the same dose of pancreatic enzymes the way it was prescribed before inclusion.
      The last four days of the fourth week, a fecal fat balance test will be repeated to quantify
      the fecal fat loss with enzyme correction. After this test the intervention takes place,
      consisting of a standardised education of the patient by a dietician. In the second phase of
      four weeks, patients are stimulated to use this information to self-dose the amount of
      pancreatic enzymes according to the fat content of their diet. In the last week of the study
      a fecal fat balance test will be repeated.

      The primary endpoint is the fecal fat excretion. Secondary endpoints are the change in enzyme
      dose after intervention, improvement of complaints (e.g. steatorrhoea related complaints,
      abdominal cramps, abdominal pain), change in dietary habits, patient satisfaction, quality of
      life, evaluation of the nutritional status, and the occurrence of side effects.

      Because the maximum amount of 16 capsules of pancreatic enzymes a day according to the
      standard guidelines will not be exceeded in this trial, no risks are foreseen. The
      anticipated benefit of the study is that patients will be treated more effectively for their
      EPI. The burden of this trial for patients is the repeated fecal fat balance test.
    

Intervention name(s): Panzytrat 25.000 FIP-E units of Lipase
Intervention type(s): Drug
Intervention description(s): patients will experiment with Panzytrat (containing 25.000 units of lipase) to a maximum of 16 capsules a day according to general guidelines.
Other intervention name(s): Pancreatine of porcine-origin
Intervention MeSH terms: Pancreatin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic pancreatitis; Exocrine insufficiency; Pancreatic enzyme replacement therapy; Self-administration