What are the recommended labs and treatment for pancreatic insufficiency?

From the Guidelines

For pancreatic insufficiency, the recommended diagnostic labs include fecal elastase test, with levels <100 mg/g of stool providing good evidence of EPI, and serum nutritional markers like fat-soluble vitamins (A, D, E, K), and treatment primarily consists of pancreatic enzyme replacement therapy (PERT) with an initial dose of at least 40,000 USP units of lipase during each meal in adults. The diagnosis of pancreatic insufficiency should be suspected in patients with high-risk clinical conditions, such as chronic pancreatitis, relapsing acute pancreatitis, pancreatic ductal adenocarcinoma, cystic fibrosis, and previous pancreatic surgery 1. The fecal elastase test is the most appropriate initial test and must be performed on a semi-solid or solid stool specimen, with levels <100 mg/g of stool providing good evidence of EPI, and levels of 100–200 mg/g are indeterminate for EPI 1. Some key points to consider in the treatment of pancreatic insufficiency include:

• PERT should be taken during the meal, with the initial treatment of at least 40,000 USP units of lipase during each meal in adults and one-half of that with snacks 1.
• Routine supplementation and monitoring of fat-soluble vitamin levels are appropriate, and dietary modifications include a low-moderate fat diet with frequent smaller meals and avoiding very-low-fat diets 1.
• Measures of successful treatment with PERT include reduction in steatorrhea and associated gastrointestinal symptoms; a gain of weight, muscle mass, and muscle function; and improvement in fat-soluble vitamin levels 1.
• EPI should be monitored, and baseline measurements of nutritional status should be obtained, including body mass index, quality-of-life measure, and fat-soluble vitamin levels, and a baseline dual-energy x-ray absorptiometry scan should be obtained and repeated every 1–2 years 1. The treatment response to PERT should be measured to ensure that adequate doses are being taken, that they are taken correctly, and to assess the need for prescribing H2 receptor antagonist or proton pump inhibitors 1. In clinical practice, administration of enzyme microspheres to infants can be difficult, and if the infant refuses to take the enzyme microspheres, administration with an acidic puree or use of unprotected powder enzymes may be considered 1. For patients of all ages, powder enzymes can be used to help digest enteral tube feedings, and enzymes given in this situation should not be mixed with the feed; they should be administered as bolus doses through the enteral feeding tube 1. There is no evidence on the optimum time to start treatment or on how to adjust dosages of enzymes for people with different severity of pancreatic insufficiency; well-designed trials are needed to answer these questions 1. For those being treated with PERT, monitoring at growth and/or nutritional status at regular intervals to determine the adequacy of treatment is recommended, at every clinic visit for infants, every 3 months for older children and adolescents, and every 6 months for adults 1.

From the Research

Pancreatic Insufficiency Labs

The diagnosis of pancreatic insufficiency can be facilitated through various laboratory tests, including:

• Fecal elastase-1 (FE-1) test, which is a non-invasive and reliable method for evaluating pancreatic function 2, 3, 4, 5
• Fecal fat quantification, which is an accurate test for pancreatic exocrine insufficiency 6
• (13)C-mixed triglycerides test, which is also an accurate test for pancreatic exocrine insufficiency 6
• Blood tests to assess signs of malnutrition 6
• Imaging tests to assess morphological severity of chronic pancreatitis 6

Treatment of Pancreatic Insufficiency

The treatment of pancreatic insufficiency includes:

• Support to stop smoking and alcohol consumption 6
• Dietary consultation 6
• Enzyme replacement therapy, which should be administered in the form of enteric-coated minimicrospheres during meals 6
• A structured follow-up of nutritional status and the effect of treatment 6
• The dose of enzyme replacement therapy should be in proportion to the fat content of the meal, usually 40-50000 lipase units per main meal, and half the dose is required for a snack 6
• In cases that do not respond to initial treatment, the doses can be doubled, and proton inhibitors can be added to the treatment 6

Considerations for Lab Tests

When interpreting the results of lab tests for pancreatic insufficiency, it is essential to consider the following:

• The FE-1 test may be inconclusive in patients with a less clear clinical picture due to significant intra-patient variability 3
• The test results may be affected by the timing of stool sample collection and the individual's diet 5
• A borderline area of +/- 25% of the recommended cut off of 200 micrograms/g stool should be used for the diagnosis of pancreatic insufficiency 5