Summary and recommendations from the Australasian guidelines for the management of pancreatic exocrine insufficiency

doi:10.1016/j.pan.2015.12.006

Pancreatology

Volume 16, Issue 2, March–April 2016, Pages 164-180

https://doi.org/10.1016/j.pan.2015.12.006 Get rights and content

Abstract

Aim

Because of increasing awareness of variations in the use of pancreatic exocrine replacement therapy, the Australasian Pancreatic Club decided it was timely to re-review the literature and create new Australasian guidelines for the management of pancreatic exocrine insufficiency (PEI).

Methods

A working party of expert clinicians was convened and initially determined that by dividing the types of presentation into three categories for the likelihood of PEI (definite, possible and unlikely) they were able to consider the difficulties of diagnosing PEI and relate these to the value of treatment for each diagnostic category.

Results and conclusions

Recent studies confirm that patients with chronic pancreatitis receive similar benefit from pancreatic exocrine replacement therapy (PERT) to that established in children with cystic fibrosis. Severe acute pancreatitis is frequently followed by PEI and PERT should be considered for these patients because of their nutritional requirements. Evidence is also becoming stronger for the benefits of PERT in patients with unresectable pancreatic cancer. However there is as yet no clear guide to help identify those patients in the ‘unlikely’ PEI group who would benefit from PERT. For example, patients with coeliac disease, diabetes mellitus, irritable bowel syndrome and weight loss in the elderly may occasionally be given a trial of PERT, but determining its effectiveness will be difficult. The starting dose of PERT should be from 25,000–40,000 IU lipase taken with food. This may need to be titrated up and there may be a need for proton pump inhibitors in some patients to improve efficacy.

Introduction

In 2014 The Australasian Pancreatic Club felt that it was time to revisit the 2009 Australasian Guidelines for the Management of Pancreatic Exocrine Insufficiency because of several new relevant concepts and publications. A working party of expert independent clinicians was convened under the Chairmanship of E/Professor Ross Smith, APC President. It was particularly noted that there was still some confusion in the medical community about indications for prescribing and effective dosage of pancreatic exocrine replacement therapy (PERT). Further that the cost of PERT was significant for the community and therefore the indications should be carefully defined. The working party agreed that it was important for this document to be independent of influence from the pharmaceutical industry.

Section snippets

Methods

Members of the working party, who were assigned topics for review, conducted new literature searches. Final formatting and editorial assistance was obtained from an independent editor, S.S. As part of their review, working party members were to make recommendations based on levels of evidence according to the Oxford Centre for Evidence Based Medicine (CEBM) v1, www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009/, with the inclusion of a category 3c: Critical review of

Symptoms of PEI

PEI results in a cluster of symptoms including abdominal pain, diarrhoea, weight loss and malnutrition.

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The severity of the symptoms depends on the degree of PEI. Steatorrhoea and associated symptoms are not evident until duodenal lipase falls below 5–10% of normal postprandial levels [2], [3].

Clinical consequences of PEI

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The most common is fat maldigestion
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Maldigestion can result in steatorrhoea and weight loss (or failure to thrive in children),
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Maldigestion is not always obvious; levels of micronutrients, fat-soluble

Key points

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Pancreatic exocrine replacement therapy (PERT) is the main pharmacological treatment for PEI. Modern preparations contain pancreatic extract encapsulated in micro tablets or (mini)microspheres with pH-sensitive enteric coating.
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The microspheres mix intragastrically with chyme while being protected from acid degradation by the enteric coating. The enzymes are then emptied from the stomach simultaneously with the chyme. The higher pH in the duodenum dissolves the enteric coating, releasing the

Key points

The main consequence of PEI is malabsorption of fat and protein and therefore also of vitamins and trace elements. Routine nutritional assessment is essential to ensure the early detection of malnutrition [2].

One important issue is the need to avert the development of osteoporosis or osteopenia [21].

There was no improvement in nutritional status with nutritional supplements over a home made balanced diet when patients are using PERT [22].

Key points

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Acute pancreatitis is an inflammatory disease associated with significant morbidity and mortality.
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While there is no evidence to support the use of PERT during the initial stages of acute pancreatitis [25], the data do support the fact that some patients have pancreatic exocrine dysfunction for a period of time after experiencing acute pancreatitis. Nine cohort studies in patients measured pancreatic function in the early recovery phase and over time [26], [27], [28], [29], [30], [31], [32], [33]

Key points

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One of the most common causes of PEI is chronic pancreatitis. Alcohol is considered the primary cause. The progressive loss of pancreatic parenchyma leads to impaired exocrine function. Maldigestion occurs in the majority of patients with chronic pancreatitis. However, clinical diagnoses of steatorrhoea and exocrine insufficiency are usually not made until relatively late in the course of the disease.
▪
It must be remembered that the presence of steatorrhoea, either proven or implied, is the

Key points

▪
Cystic fibrosis (CF) is a common lethal genetic disorder caused by mutations in the gene that encodes the CFTR protein. CFTR mutations disrupt the function of water and chloride ion transportation at a cellular level, leading to classic CF phenotypes such as raised sweat chloride, recurrent respiratory infection with bronchiectasis and early-onset pancreatic insufficiency.
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Most cases of CF are diagnosed shortly after birth through screening.
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The long-term survival for children with CF has

Key points

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Pancreatic hyperplasia and a decrease in pancreatic digestive enzymes are consequences of bowel surgery, (level of evidence 2a). However the digestive consequences of bowel resection are subject to considerable individual variation, largely due to the site and extent of resection. There is limited information in recent published literature concerning PEI in patients after bowel surgery, although the consensus is that it does occur and particularly affects those patients who have undergone

Key points

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A majority of patients develop maldigestion after gastric surgery. This can be due to multiple and complex factors which need to be investigated before resorting to PERT [55], [56] (level of evidence 3b).
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The majority of patients develop a degree of PEI after gastric surgery but for most this does not affect their wellbeing [57] (level of evidence 2a). Patients whose wellbeing is not severely affected after gastric surgery do not require long term PERT.
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All post gastrectomy patients require

Key points

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Major pancreatic resections impair not only pancreatic function but also the function of the entire upper gastrointestinal tract. This can adversely affect the nutritional status and overall quality of life of the patients concerned.
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Current literature suggests that with advances in surgical techniques and post-operative care (including optimal pancreatic enzyme replacement), the majority of patients will have good outcomes with minimal gastrointestinal symptoms after pancreatic resection, will

Key points

▪
Pancreatic cancer is associated with a poor prognosis. Many patients present at an advanced stage, when curative surgery is not an option.
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About 90% of patients with pancreatic cancer have weight loss at the time of diagnosis. Weight loss may be exacerbated by malabsorption, as a result of pancreatic duct obstruction and destroyed pancreatic tissue, reducing the availability of pancreatic enzymes. This results in PEI with associated steatorrhoea.
▪
Even if patients do not have PEI at the time of

Key points

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The proportion of diabetes that is pancreatogenic, type 3c, is likely to be underestimated, but may be as high as 5–10% in western nations [73].
▪
There are specific management considerations in type 3c diabetes related to the pancreatic condition. More evidence is needed to determine the benefits of stringent attempts to exclude a pancreatic cause in patients who were otherwise thought to have type 1 or 2 diabetes.
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Pancreatic exocrine deficiency is prevalent in type 1 or 2 diabetes when patients

Key points

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The secretion of digestive enzymes into the duodenum is controlled by humoral and neural factors. For obvious reasons these enteropancreatic pathway [81] factors are closely interrelated with the functional integrity of the small intestinal mucosa (e.g. by the release of regulatory peptides). While available data are limited because of, e.g., small sample size and the use of indirect tests that might be affected by impaired intestinal absorptive capacity, there is sufficient evidence to assume

Key points

Irritable bowel syndrome (IBS) is a common condition characterised by disturbed defaecation including diarrhoea, abdominal pain, and often bloating. PEI may occur in a small subset of patients with diarrhoea-predominant IBS but the prevalence is unclear. Treatment with PERT may reduce diarrhoea and abdominal pain regardless of the presence of PEI, based on preliminary evidence, but better-designed clinical trials are now needed to confirm the initial observations.

Recommendations

There are no evidence-based strategies for management of the elderly patient (over 65 years) who might have a failing exocrine pancreas. However, several papers have indicated the importance of PEI as a cause of weight loss in these patients and these recommendations are suggested – all are Level 5 (expert opinion).

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Acute pancreatitis (AP) is one of the most common gastrointestinal diseases in the emergency department and hospitalization setting. Its incidence is progressively increasing and the main etiologies are cholelithiasis and alcohol. The diagnosis is based on clinical, analytical, and radiological criteria. There are other diseases with similar clinical and analytical abnormalities and thus, it is necessary to make a correct differential diagnosis. The initial treatment is symptomatic (analgesia) and supportive (serum therapy based on targets). Monitoring is especially important for the early identification of patients with poor progress. The treatment for moderately severe AP is based on organ failure support, specific pharmacological treatment in selected cases (antibiotic therapy), nutritional treatment, and interventional treatment for symptomatic pancreatic necrosis. The treatment for cases of moderately severe AP must take place, when possible, in reference centers with multidisciplinary teams. Etiological treatment of the cause of pancreatitis is essential for preventing new episodes.
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Citation Excerpt :
Patients were prescribed PERT either pre or post-surgery with the timing and dose based on the recommendations provided by the Australasian Guidelines for the management of pancreatic exocrine insufficiency. Need for PERT was based on faecal elastase-1, clinical symptoms of PEI, nutritional status and the presence of fat-soluble vitamin deficiency, evident at time of initial assessment [3]. Patients with HbA1c >7% were referred to an endocrinologist.
Pancreatic resection is associated with pancreatic exocrine insufficiency (PEI) leading to nutritional consequences. The Pancreatic Nutrition Clinic was established to diagnose and manage PEI through standardised nutritional assessment. In this prospective observational study, we aimed to define the rate of PEI, diabetes mellitus and nutritional abnormalities in patients who underwent pancreatic resection.
All Pancreatic Nutrition Clinic patients were included for analysis. Clinical data were prospectively obtained at initial assessment. Biochemical data included micronutrient levels, faecal elastase-1 and haemoglobin A1c. Bone mineral density and nutritional assessment were undertaken.
Ninety-eight patients were included. Fifty-nine per cent (58/98) had undergone a pancreatoduodenectomy. Ninety-three patients had a faecal elastase-1 result, 65% (60/93) of which had a faecal elastase-1 less than 200 μg/g of faeces. Seventy-five patients (76%) of the total population required PERT, and thirty-nine (40%) were classified as malnourished using the patient-generated subjective global assessment tool. Seventy-two per cent (70/97) had a biochemical deficiency of one or more micronutrients. Thirty-eight people (39%) had diabetes mellitus. Of the seventy-eight patients with a bone mineral density scan available for analysis, 29% (23/78) had osteoporosis and 49% (38/78) osteopenia.
Pancreatic exocrine insufficiency, micronutrient deficiency, bone disease, diabetes mellitus and malnutrition are highly prevalent in patients who have undergone pancreatic resection.
Diagnosis and treatment of exocrine pancreatic insufficiency in chronic pancreatitis: An international expert survey and case vignette study
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Despite evidence-based guidelines, exocrine pancreatic insufficiency is frequently underdiagnosed and undertreated in patients with chronic pancreatitis. Therefore, the aim of this study is to provide insight into the current opinion and clinical decision-making of international pancreatologists regarding the management of exocrine pancreatic insufficiency.
An online survey and case vignette study was sent to experts in chronic pancreatitis and members of various pancreatic associations: EPC, E-AHPBA and DPSG. Experts were selected based on publication record from the past 5 years.
Overall, 252 pancreatologists participated of whom 44% had ≥ 15 years of experience and 35% treated ≥ 50 patients with chronic pancreatitis per year. Screening for exocrine pancreatic insufficiency as part of the diagnostic work-up for chronic pancreatitis is performed by 69% and repeated annually by 21%. About 74% considers nutritional assessment to be part of the standard work-up. Patients are most frequently screened for deficiencies of calcium (47%), iron (42%), vitamin D (61%) and albumin (59%). In case of clinically steatorrhea, 71% prescribes enzyme supplementation. Of all pancreatologists, 40% refers more than half of their patients to a dietician. Despite existing guidelines, 97% supports the need for more specific and tailored instructions regarding the management of exocrine pancreatic insufficiency.
This survey identified a lack of consensus and substantial practice variation among international pancreatologists regarding guidelines pertaining the management of exocrine pancreatic insufficiency. These results highlight the need for further adaptation of these guidelines according to current expert opinion and the level of available scientific evidence.
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Pancreatic exocrine insufficiency (PEI) is a common condition in patients with pancreatic cancer (PC). PEI can be due to the tumor, which, if located in the head, causes obstruction of the pancreatic duct with subsequent atrophy of the pancreatic parenchyma, or it can be the consequence of pancreatic surgical resection. The standard treatment of PEI is pancreatic enzyme replacement therapy (PERT). Clinical data to support the use of PERT in PC are however limited. There are very few randomized clinical trials that evaluated PERT in PC. Most data come from observational studies. Despite this limited clinical evidence, PERT treatment for PEI is an essential part of supportive therapy to ensure optimal nutritional status in PC patients who will receive surgery, neoadjuvant/adjuvant or palliative treatment. The objective of this review is to increase the awareness about PEI in PC patients and to provide expert recommendations on the use of PERT in resected, borderline resectable and unresectable patients, based on clinical experience and literature review.
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Citation Excerpt :
The treatment of PEI is pancreatic enzyme replacement therapy (PERT) given as pancrelipase or pancreatin, a combination of protease, amylase, and lipase (Fig. 1). Possible benefits of treatment include resolution of gastrointestinal symptoms, improved quality of life, better glycemic control, decreased maldigestion-induced hypoglycemia, and optimal absorption of fat soluble vitamins (A, D, E, K) (76–79). Replacement of any vitamin or mineral deficiencies should occur simultaneously with PERT.
Objective: Type 1 diabetes (T1D) is characterized by autoimmune β-cell destruction, but exocrine pancreas abnormalities may also play a role in the disease pathophysiology. Herein, we review the current evidence of exocrine damage in T1D and discuss its underlying pathophysiology, clinical evaluation, and treatment.
Method: Extensive literature search was performed for “type 1 diabetes” and “exocrine dysfunction” on PubMed and Google Scholar databases.
Results: T1D pancreata are significantly smaller than controls, both in weight and volume. T cells, dendritic cells, neutrophils, and products of complement activation are seen in T1D exocrine tissues. Exocrine pancreas fibrosis, arteriosclerosis, fatty infiltration, and acinar atrophy are also observed on histology. Pancreatic exocrine insufficiency (PEI) can be assessed through direct exocrine testing, fecal elastase concentration, and measurement of serum exocrine enzymes. The prevalence of PEI in T1D varies by modality and study but is consistently greater than controls. The clinical relevance of PEI in T1D is debatable, as many patients with laboratory evidence of PEI are asymptomatic. However, in PEI-symptomatic patients reported benefits of pancreatic enzyme replacement therapy (PERT) include relief of gastrointestinal symptoms, improved quality of life, better glycemic control, and optimal nutrition.
Conclusion: Exocrine pancreas abnormalities often occur in T1D. Whether exocrine dysfunction occurs simultaneously with β-cell destruction, as a result of β-cell loss, or as a combination of both remains to be definitively answered. In T1D with gastrointestinal complaints, PEI should be evaluated, usually via fecal elastase measurements. PERT is recommended for T1D patients with symptoms and laboratory evidence of PEI.
Abbreviations: AAb+ = autoantibody positive; AAb- = autoantibody negative; FEC = fecal elastase concentration; PEI = pancreatic exocrine insufficiency; PERT = pancreatic enzyme replacement therapy; PP = pancreatic polypep-tide; T1D = type 1 diabetes

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Review articleSummary and recommendations from the Australasian guidelines for the management of pancreatic exocrine insufficiency

Abstract

Aim

Methods

Results and conclusions

Introduction

Section snippets

Methods

Symptoms of PEI

Clinical consequences of PEI

Key points

Key points

Key points

Key points

Key points

Key points

Key points

Key points

Key points

Key points

Key points

Key points

Recommendations

Pancreatology

Pancreatology

Pancreatology

Gastrointest Endosc

Clin Gastroenterol Hepatol

Pancreatology

HPB (Oxford)

Gastroenterology

Gastroenterology

J Clin Epidemiol

J Am Diet Assoc

Best Pract Res Clin Gastroenterol

HPB (Oxford)

Eur J Intern Med

Auton Neurosci

Gastroenterology

Clin Gastroenterol Hepatol

Chronic pancreatitis–definition, etiology, investigation and treatment

Dtsch Arztebl Int

Human pancreatic exocrine response to nutrients in health and disease

Gut

Relations between pancreatic enzyme outputs and malabsorption in severe pancreatic insufficiency

N Engl J Med

Lipoproteins and chronic pancreatitis

Pancreas

The prevalence of malnutrition and fat-soluble vitamin deficiencies in chronic pancreatitis

Nutr Clin Pract

Fat malabsorption screening in chronic pancreatitis

Am J Gastroenterol

Post-ERCP acute pancreatitis and its risk factors

J Med Life

Diagnosis of mild chronic pancreatitis (Cambridge classification): comparative study using secretin injection-magnetic resonance cholangiopancreatography and endoscopic retrograde pancreatography

World J Gastroenterol

Does secretin-stimulated MRCP predict exocrine pancreatic insufficiency?: a comparison with noninvasive exocrine pancreatic function tests

J Clin Gastroenterol

Pancreatic function tests for diagnosis and staging of chronic pancreatitis, cystic fibrosis, and exocrine pancreatic insufficiency of other etiologies:which tests are necessary and how should they be performed in clinical routine?

Combined endoscopic ultrasound and secretin endoscopic pancreatic function test in patients evaluated for chronic pancreatitis

Dig Dis Sci

Pancreatic enzyme replacement therapy in cystic fibrosis: Australian guidelines. Pediatric Gastroenterological Society and the Dietitians Association of Australia

J Paediatr Child Health

Effect of the administration schedule on the therapeutic efficacy of oral pancreatic enzyme supplements in patients with exocrine pancreatic insufficiency: a randomized, three-way crossover study

Aliment Pharmacol Ther

Delayed release pancrelipase for the treatment of pancreatic exocrine insufficiency associated with cystic fibrosis

Ther Clin Risk Manag

Improvement of fecal fat excretion after addition of omeprazole to pancrease in cystic fibrosis is related to residual exocrine function of the pancreas

Dig Dis Sci

guidelines on osteoporosis in gastrointestinal diseases

Gastroenterology

The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea: a multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis

Pancreas

Pancreatic enzyme supplementation in acute pancreatitis

HPB Surg

Natural history of acute pancreatitis: a long-term population-based study

Am J Gastroenterol

Acute alcoholic pancreatitis does not lead to complete recovery

Mater Med Pol

Exocrine pancreatic function after alcoholic or biliary acute pancreatitis

Review article
Summary and recommendations from the Australasian guidelines for the management of pancreatic exocrine insufficiency