Synopsis of recent guidelines on pancreatic exocrine insufficiency

Abstract

Background: In recent years, three national gastroenterology societies established guidelines for the diagnosis and therapy of pancreatic exocrine insufficiency (PEI). In addition, the Cochrane Collaboration issued a review. Objective: The purpose of this paper is to present an overview of the recommendations and concordance between the four recent published guidelines and stimulate further discussion. Methods: A review of the Australian, German and Italian guidelines and the Cochrane review was conducted, and a synthesis was made of common statements.Results: There is a high degree of agreement on almost all items within these guidelines, both in the diagnosis of PEI and in terms of therapy and approach to management of PEI. In addition, novel emerging developments are highlighted, such as the fecal elastase-1 test, which is widely used but is not suitable for measuring mild-to-moderate PEI despite its ability to positively establish the diagnosis of severe PEI. One of the few novel tests proving to be useful is the 13 C mixed-chain triglycerides (MCT) breath test. This test, albeit an excellent quantitative test, is not widely used and is rarely available. The use of this test is making it apparent that there is a difference between treating the symptoms of PEI and treating malnutrition, the broader underlying defect. This may have direct consequences for the dosing of pancreatic enzymes (pancreatin), in that the consensus starting dose of all guidelines may be too low for some patients. Although chronic pancreatitis in adults and cystic fibrosis in children account for the main evidence base used for PEI, other indications are also discussed. Conclusions: There is good concordance between recommendations provided by international groups. More prospective studies are required in many areas, including the use of pancreatic enzymes in other gastrointestinal disorders, such as celiac disease and irritable bowel syndrome (IBS). We also need to assess the feasibility of the 13 C MCT breath test. At the same time, it needs to be confirmed that higher doses of pancreatic enzymes are really necessary to not only relieve the symptoms of PEI but also treat malnutrition appropriately.

Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test

“…Despite these limitations, the US Food and Drug Administration and the European Medicines Agency require the use of CFA quantification for the diagnosis of PEI and the evaluation of PERT efficacy in clinical trials. Although FE-1 testing is not a requirement in clinical trials, it has been investigated as a diagnostic tool for PEI in a large number of studies, and some countries' guidelines suggest that it be used to establish a diagnosis of PEI prior to commencing treatment with PERT [58,59]. However, an exception to this would be PEI due to surgical diversion of the intestine, where FE-1 can have false-negative results and PERT may be indicated even when FE-1 results are normal.…”

Pancreatic Exocrine Insufficiency in Pancreatic Cancer

“…Pancreatic exocrine insufficiency (PEI) is defined as the condition in which the amount of secreted pancreatic enzymes is insufficient to maintain normal digestion [5], while pancreatic cancer is a typical condition in which normal pancreatic exocrine secretion is impaired due to chronic obstructive damage to the secreting component of the organ. …”

Total pancreatectomy for recurrent acute and chronic pancreatitis: a critical review of patient selection criteria

“…However, the pancreas has a large functional reserve, and malabsorption leading to steatorrhea is not expected until lipase output is reduced to less than 10% of normal [54]. Multiple tests are available for the detection of PEI, including fecal elastase-1 (FE-1), C 13 mixed-triglyceride breath test (MTG-BT), and the pancreatic function test (PFT) [55]. …”

“…However, it only has sensitivity between 54 and 75% (Table 1) [56–58]. Furthermore, there is no consensus regarding the threshold for diagnosing PEI using FE-1, and values ranging from 15 to 200 μg/g have been suggested in the literature (Table 1) [31,55,59]. A recent prospective study comparing FE-1, MTG-BT, and a 72-h fecal fat test found that a cut-off value of 84 μg/g was associated with a sensitivity and specificity of 87.5 and 66.7% for PEI, respectively (Table 1).…”