From the Guidelines
Diagnosing exocrine pancreatic insufficiency (EPI) should be based on a combination of clinical assessment and the fecal elastase test, which is the most appropriate initial test, as it is non-invasive and not affected by pancreatic enzyme replacement therapy 1.
Clinical Assessment
The diagnosis of EPI should be considered in patients with high-risk clinical conditions, such as chronic pancreatitis, relapsing acute pancreatitis, pancreatic ductal adenocarcinoma, cystic fibrosis, and previous pancreatic surgery, as well as those with moderate-risk conditions like duodenal diseases, previous intestinal surgery, longstanding diabetes mellitus, and hyper-secretory states 1. Clinical features of EPI include steatorrhea with or without diarrhea, weight loss, bloating, excessive flatulence, fat-soluble vitamin deficiencies, and protein-calorie malnutrition.
Diagnostic Tests
- The fecal elastase test is the preferred initial test, with a level <100 mg/g of stool providing good evidence of EPI, and levels of 100–200 mg/g being indeterminate for EPI 1.
- Fecal fat testing is rarely needed and must be performed when on a high-fat diet, with quantitative testing generally not practical for routine clinical use 1.
- Response to a therapeutic trial of pancreatic enzymes is unreliable for EPI diagnosis 1.
- Cross-sectional imaging methods, such as computed tomography scan, magnetic resonance imaging, and endoscopic ultrasound, cannot identify EPI but play an important role in diagnosing benign and malignant pancreatic disease 1.
- Breath tests and direct pancreatic function tests hold promise but are not widely available in the United States 1.
Importance of Accurate Diagnosis
Accurate diagnosis of EPI is crucial to initiate appropriate treatment with pancreatic enzyme replacement therapy (PERT), which can improve outcomes, reduce complications related to fat malabsorption and malnutrition, and enhance quality of life 1. Untreated EPI can lead to severe malnutrition, increased mortality, and a significant negative impact on the patient's quality of life. Therefore, a prompt and accurate diagnosis of EPI using the fecal elastase test and clinical assessment is essential to guide effective management and improve patient outcomes.
From the Research
Diagnosis of Exocrine Pancreatic Insufficiency
The diagnosis of exocrine pancreatic insufficiency (EPI) is based on a set of symptoms, indicators of malnutrition, and an indirect non-invasive test in at-risk patients 2. The most commonly used test for diagnosing EPI is the fecal elastase test, which is considered the most clinically useful test 3. Other tests available for diagnosing EPI include fecal fat quantification and the (13) C-triglyceride breath test 4.
Diagnostic Criteria
The diagnostic criteria for EPI include:
- Clinical manifestations such as abdominal cramps, steatorrhea, and malnutrition 4
- Indicators of malnutrition, such as weight loss and malabsorption 2
- Abnormal test results, such as low fecal elastase levels 3
At-Risk Patient Populations
High-risk patient populations for EPI include:
- Those with chronic pancreatitis 2, 3
- Those with cystic fibrosis 2
- Those with a history of extensive necrotizing acute pancreatitis 5
- Those with pancreatic cancer or pancreatic surgery 3, 4
- Those with gastrointestinal and pancreatic surgical resections 4
Importance of Early Diagnosis
Early diagnosis of EPI is important to prevent malnutrition and related complications, such as osteoporosis and cardiovascular events 2, 3. It is also important to ensure that patients receive appropriate treatment, including pancreatic enzyme replacement therapy, to improve their nutritional status and quality of life 2, 3, 6.