Frequency of Appropriate Use of Pancreatic Enzyme Replacement Therapy and Symptomatic Response in Pancreatic Cancer Patients.

OBJECTIVES: Pancreatic cancer (PC) and its treatments can result in pancreatic exocrine insufficiency that requires pancreatic enzyme replacement therapy (PERT). Appropriate PERT usage is during meals and snacks. The aim was to determine the frequency of appropriate use of PERT and its impact on symptom alleviation in PC through a patient-reported outcomes online platform. METHODS: Users in the Pancreatic Cancer Action Network's Patient Registry were prompted to answer a standalone questionnaire about their experience with PERT. RESULTS: Two hundred sixty-two users completed the PERT questionnaire (January 2016-January 2018). Patients who reported taking PERT with meals had higher alleviation of symptoms compared with those taking PERT prior to or after meals. Specifically, "feeling of indigestion," "light-colored or orange stools," and "visible food particles in stool" were significantly decreased. Patients taking PERT with meals reported weight gain and less weight loss. CONCLUSIONS: Of the 89% of PC patients prescribed PERT, 65% were prescribed PERT appropriately with all meals and snacks. Overall compliance with PERT administration guidelines was low (50% [105/208]). Improvement in symptoms significantly correlated with appropriate use of PERT. Increase in PC patient and provider education about appropriate PERT usage and administration is warranted.

Nondietary Therapies for Celiac Disease.

Celiac disease (CD) is an autoimmune enteropathy triggered by gluten. Gluten-free diets can be challenging because of their restrictive nature, inadvertent cross-contaminations, and the high cost of gluten-free food. Novel nondietary therapies are at the preclinical stage, clinical trial phase, or have already been developed for other indications and are now being applied to CD. These therapies include enzymatic gluten degradation, binding and sequestration of gluten, restoration of epithelial tight junction barrier function, inhibition of tissue transglutaminase-mediated potentiation of gliadin oligopeptide immunogenicity or of human leukocyte antigen-mediated gliadin presentation, induction of tolerance to gluten, and antiinflammatory interventions.

Randomized placebo controlled clinical trial of an enteric coated micro-pelleted formulation of a pancreatic enzyme supplement in dogs with exocrine pancreatic insufficiency.

BACKGROUND: Pancreatic enzyme supplements for the treatment of exocrine pancreatic insufficiency (EPI) in dogs can be uncoated or enteric coated. Enteric coated supplements might be advantageous. HYPOTHESIS/OBJECTIVES: Enteric coated enzyme supplements are superior to uncoated supplements in dogs with clinical EPI. ANIMALS: Eleven dogs with naturally occurring EPI that were apparently free from other diseases. METHODS: Randomized, blinded, controlled cross-over clinical trial comparing a novel micro-encapsulated enteric coated enzyme supplement to a commercially available uncoated product in dogs with clinical EPI. Search of serum canine serum trypsin-like immunoreactivity concentration ≤ 2.5 µg/L in the Gastrointestinal Laboratory database was used to identify dogs with EPI. RESULTS: There was no difference -4.46% (95% CI: -7.97%--0.96%; P = .15) in the % acid hydrolysis fecal fat (primary outcome) between the enteric coated formulation (median: 11.8%; range 6.4%-17.0%) and the uncoated pancreatic enzyme replacement product (median: 17.5%; range: 5.2%-24.9%) in the 11 dogs that completed the study. Other variables did not differ between treatments. CONCLUSIONS AND CLINICAL IMPORTANCE: This study, which had low statistical power, did not detect a difference between formulations.

A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer.

OBJECTIVE: Exocrine pancreatic insufficiency may impair the nutritional status in pancreatic cancer (PC), but the role of pancreatic enzyme replacement therapy (PERT) is not fully evaluated. Therefore, we conducted this multicenter open-label randomized controlled trial to evaluate the role of PERT in PC patients. METHODS: Patients with unresectable PC receiving chemotherapy were randomly assigned to pancrelipase and nonpancrelipase groups. Patients in the pancrelipase group took oral pancrelipase of 48,000 lipase units per meal. N-benzoyl-tryrosyl para-aminobenzoic acid (NBT-PABA) test was performed at baseline. Our primary endpoint was change in body mass index (BMI) at 8 weeks. Secondary endpoints were change in other nutritional status at 8 weeks and overall survival. RESULTS: A total of 88 patients were enrolled between May 2014 and May 2016. The NBT-PABA test was lower than the normal range in 90%. There were no significant differences in change in BMI at 8 weeks: 0.975 and 0.980 in the pancrelipase and the nonpancrelipase groups, respectively (P = 0.780). The other nutritional markers were also comparable. The median overall survival was 19.0 and 12.0 months (P = 0.070). CONCLUSIONS: In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.

Metabolic markers of protein maldigestion after a 15N test meal in minipigs with pancreatic exocrine insufficiency.

The effect of pancreatic exocrine insufficiency (PEI) on protein malabsorption is little documented, partly due to methodological barriers. We aimed to validate biomarkers of protein malabsorption using a 15N test meal in a minipig model of PEI. Six pancreatic duct-ligated minipigs were used as a model of PEI and four nonoperated animals as a control. All animals were equipped with an ileocecal reentrant cannula. Minipigs were given a test meal containing [15N]casein. The PEI animals repeated the test three times, in the absence of any pancreatic enzymes, or after pancreatic substitution at two levels [ A or B: 7,500 or 75,000 (lipase) and 388 or 3881 (protease) FIP U]. Ileal chyme, urine, and blood were collected postprandially. Nitrogen and 15N were measured in digestive and metabolic pools. We obtained a gradient of ileal protein digestibility from 29 ± 11% in PEI to 89 ± 6% in the controls and a dose- dependent response of enzymes. Insulin and gastric inhibitory polypeptide secretions were decreased by PEI, an effect that was counteracted with the enzymes at level B. The total recovery of 15N in urinary urea and plasma proteins was 14 ± 5.1% in the control group and decreased to 5.5 ± 2.1% by PEI. It was dose dependently restored by the treatment. Both 15N recovery in plasma and urine were correlated to protein digestibility. We confirm that the 15N transfer in those pools is a sensitive marker of protein malabsorption. Nevertheless, an optimization of the test meal conditions would be necessary in the view of implementing a clinical test. NEW & NOTEWORTHY We designed an intervention study to create a gradient of ileal protein digestibility in minipigs with pancreatic exocrine insufficiency and to validate reliable metabolic markers using a 15N oral meal test. 15N recovery in plasma proteins and to a higher extent in urine was sensitive to protein malabsorption. This test is minimally invasive and could be used to reveal protein malabsorption in patients.

Supplementation of pancreatic digestive enzymes alters the composition of intestinal microbiota in mice.

Although pancreatic enzyme replacement therapy (PERT) is effective in the alleviation of pancreatic exocrine insufficiency (PEI)-related symptoms in patients with chronic pancreatitis, its mechanism of action is poorly understood. Recent studies suggest that the intestinal microbiota is associated with the pathogenesis of chronic pancreatitis. Therefore, we hypothesized that PERT exerts its effect by modifying the intestinal microbiota in addition to its presumed role in promoting fat and protein absorption. To explore the mechanism of action of PERT, we analyzed the intestinal microbiotas of two groups of mice treated with either pancrelipase or tap water by using 16S rRNA amplicon sequencing. The results revealed that the bacterial compositions of the pancrelipase-treated mice were significantly different from those of the control samples. Akkermansia muciniphila, a key beneficial bacterium in the intestinal tract, showed a higher relative abundance in the pancrelipase-treated samples than in the control samples. Lactobacillus reuteri, a widely used probiotic bacterium known to relieve intestinal inflammation, also showed a higher relative abundance in the pancrelipase-treated samples. These results suggested that PERT induces the colonization of beneficial bacteria, thereby contributing to the attenuation of PEI-associated symptoms in addition to improvement of the nutritional state.

The Role of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer: A Prospective Cohort Study.

OBJECTIVES: Although patients with pancreatic cancer (PC) are prone to exocrine pancreatic insufficiency, there are little evidence about pancreatic enzyme replacement therapy (PERT) in patients with PC, especially those receiving chemotherapy. METHODS: This is a prospective consecutive observational study of PERT in patients with unresectable PC. We prospectively enrolled patients receiving chemotherapy for unresectable PC from April 2012 to February 2014 and prescribed oral pancrelipase of 48,000 lipase units per meal (pancrelipase group). N-benzoyl-tryrosyl para-aminobenzoic acid test was performed at baseline. Patients receiving chemotherapy before April 2012 were retrospectively studied as a historical cohort. Data on the nutritional markers at baseline and 16 weeks were extracted, and serial changes, defined as the ratio of markers at 16 weeks/baseline, were compared between 2 groups. RESULTS: A total of 91 patients (46 in the pancrelipase group and 45 in the historical cohort) were analyzed. N-benzoyl-tryrosyl para-aminobenzoic acid test was low in 94% of the pancrelipase group. Serial change in the pancrelipase group versus historical cohort was 1.01 versus 0.95 in body mass index (P < 0.001) and 1.03 versus 0.97 in serum albumin (P = 0.131). CONCLUSIONS: The rate of exocrine pancreatic insufficiency in unresectable PC was high, and PERT can potentially improve the nutritional status during chemotherapy.

Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial.

BACKGROUND: Weight loss in pancreatic cancer is associated with maldigestion due to pancreatic duct obstruction. Pancreatic exocrine replacement therapy (PERT) may significantly improve fat and protein absorption. OBJECTIVES: This prospective, double-blind, randomized, placebo-controlled phase II trial assessed whether PERT could reduce or prevent weight loss in patients with unresectable pancreatic cancer. METHODS: Sixty seven patients with unresectable pancreatic cancer were randomized to receive enteric coated PERT, consisting of 6-9 capsules of pancreatin (457.7 mg/capsule), or placebo. Patients took two capsules each three times daily during main meals and one capsule each up to three times daily when having between-meal snacks. The primary endpoint was the percentage change in body weight at eight weeks. RESULTS: The mean percentage change in body weight (1.49% [1.12 kg] vs. 2.99% [1.63 kg], P = 0.381) and the mean percent change in Patient-Generated Subjective Global Assessment (PG-SGA) score (8.85% vs. 15.69%, p = 0.18) did not differ significantly between the PERT and placebo groups. There was no improvement in quality of life and overall survival did not differ significantly between the PERT and placebo groups (5.84 months vs 8.13 months, p = 0.744). CONCLUSIONS: PERT did not reduce weight loss in patients with unresectable pancreatic cancer. Larger randomized trials are needed to identify those patients who may benefit from PERT. TRIAL REGISTRATION: ClinicalTrials.gov Number NCT01587534.

Preliminary report of the (13)C-mixed triglyceride breath test to assess timing of pancreatic enzyme replacement therapy in children with cystic fibrosis.

BACKGROUND: Despite guidelines suggesting pancreatic enzyme replacement therapy (PERT) should be taken before or during a meal, it is currently unknown whether this has benefits over administration after a meal in individuals with cystic fibrosis (CF). METHODS: 18 children with pancreatic insufficient CF were randomised to two (13)C-mixed triglyceride ((13)C-MTG) breath tests to assess lipase activity with PERT administered 10min before and 10min after a meal. Results were expressed as percentage cumulative dose recovered (PCDR) of (13)CO2 and were compared with established values in healthy subjects. Gastric half emptying time (T½) was also assessed by a (13)C-octanoate breath test. RESULTS: There was no difference in mean PCDR of (13)CO2 between taking PERT before versus after the meal (p=0.68). Eleven subjects had a greater PCDR when PERT was taken before and 7 when PERT was taken after the meal. 6/8 subjects (75%) with a lower than normal PCDR at one time point normalised PCDR when PERT timing was changed. When PERT was taken after the meal, PCDR was higher in normal vs. fast T½ (p=0.04). CONCLUSIONS: Changing PERT timing can result in normalised lipase activity. Gastric emptying rate may influence optimal timing of PERT. Clinical Trial Registration Number - This study was undertaken prior to the registration process being a commonly required practice.

Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis.

BACKGROUND: Zenpep (APT-1008) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF). METHODS: Zenpep and Kreon, both containing 25,000 lipase units, were compared in a randomised, double-blind, crossover, non-inferiority study for CF-associated EPI in patients aged ≥12years. Patients on a standardised diet and stabilised treatment were randomised to two treatment sequences: Zenpep/Kreon or Kreon/Zenpep. The primary efficacy endpoint was the coefficient of fat absorption over 72h (CFA-72h). RESULTS: 96 patients (mean age 19.2years, 60.4% males) were randomised with 83 completers of both sequences comprising the efficacy population. Zenpep demonstrated non-inferiority and equivalence to Kreon in fat absorption (LS mean CFA-72h: Zenpep, 84.1% [SE 1.1] vs. Kreon, 85.3% [SE 1.1]; p=0.297). Safety and tolerability were similar. CONCLUSIONS: Zenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI. NCT01641393.

Do pancrelipase delayed-release capsules have a protective role against nonalcoholic fatty liver disease after pancreatoduodenectomy in patients with pancreatic cancer? A randomized controlled trial.

BACKGROUND: The aim of this randomized controlled trial (RCT) was to investigate whether pancrelipase protects against nonalcoholic fatty liver disease (NAFLD) development after pancreatoduodenectomy in patients with pancreatic cancer better than conventional pancreatic enzyme supplementation. METHODS: A total of 57 patients were randomly assigned to the study group (n = 29; pancrelipase replacement therapy) or the control group (n = 28; conventional pancreatic enzyme supplementation). NAFLD was defined as a liver-to-spleen attenuation ratio less than 0.9 on CT. Clinical and laboratory findings were also assessed. RESULTS: NAFLD was observed in 6/29 patients (21%) in the study group, and 11/28 patients (39%) in the control group, but this was not a statistically significant difference. In the control group, crossover to pancrelipase replacement therapy upon NAFLD diagnosis produced improvement in five out of 10 patients. Multivariate analysis showed that advanced age and extended resection were independent risk factors for NAFLD development. CONCLUSION: This RCT did not show a significant protective effect of pancrelipase replacement therapy over conventional pancreatic enzyme supplementation on NAFLD development after pancreatoduodenectomy for pancreatic cancer. Further studies are clearly required to investigate the etiology of and new therapeutic strategies for treatment-resistant NAFLD (UMIN 000019817).

Challenges of Administering Pancrelipase in Pancreatitis Patients.

OBJECTIVE: This study evaluated nutrition status to determine the impact of a novel approach using elemental nutrition compared to pancrelipase administration in patients with pancreatitis. METHODS: This retrospective study included adult patients with pancreatitis who were nil per os (NPO) and received elemental nutrition from August 2008 to 2010 (n = 24) or pancrelipase enzyme supplementation (PES) plus nonelemental enteral nutrition from August 2011 to 2013 (n = 41) at a large academic medical center. The primary outcome is the percentage of diarrhea-free days. Secondary outcomes include time-to-goal enteral nutrition from the enteral nutrition initiation and pre-albumin and albumin changes pre- and postenteral nutrition. RESULTS: There were no statistically significant differences between the 2 groups in percentage of diarrhea-free days (46.80% ± 29.03% vs 53.45% ± 36.76%, p = 0.45). Additionally, there were no differences in secondary outcomes of time-to-goal enteral nutrition and pre-albumin and albumin changes pre- and postenteral nutrition. CONCLUSION: Utilizing elemental nutrition compared to PES plus nonelemental enteral nutrition in patients with pancreatitis was not associated with a significant reduction in percentage of diarrhea-free days, time-to-goal enteral nutrition, and nutrition status. A multicenter, prospective, randomized, controlled trial is warranted to further evaluate the efficacy of elemental nutrition in patients with pancreatitis.

Pancrelipase with branched-chain amino acids for preventing nonalcoholic fatty liver disease after pancreaticoduodenectomy.

BACKGROUND: To investigate the efficacy of the early administration of pancreatic enzymes combined with an elemental diet of branched-chain amino acids (BCAA) for nonalcoholic fatty liver disease (NAFLD) after pancreaticoduodenectomy (PD). METHODS: Data were obtained for 122 consecutive patients who underwent PD. High-titer pancrelipase and a BCAA-rich solution was administered via a feeding tube beginning on postoperative day (POD) 4 (PB group: n = 31). Ninety-one patients who underwent PD prior to this treatment were included as a control group (n = 91). The radiological changes in the liver and pancreatic parenchyma related to NAFLD before and after PD were assessed on CT, and trends in liver function and nutritional status were evaluated over the 180-day post-PD period. RESULTS: Patient background factors, histopathology and operation-related variables were not significantly different between the two groups. Liver attenuation [56 HU (-13 to 73) vs. 61 (26 to 69), p = 0.015] and the liver-to-spleen attenuation ratio [1.12 (-0.38 to 1.48) vs. 1.24 (0.89 to 1.49), p = 0.018] were significantly decreased, and the pancreatic parenchyma was significantly thinner [17.9 mm (8.6-25.3) vs. 13.9 mm (2.5-23.2), p = 0.02] in the control group at 3 months after the operation. The alanine aminotransferase levels were also higher in the control group (p < 0.05, at POD 14, 30, 60 and 90), while the serum albumin (p < 0.05, at POD 30, 60 and 180) and total protein (p < 0.05, at POD 30, 60, 90 and 180) levels were significantly better in the PB group. CONCLUSIONS: Early supplementation of high-titer pancrelipase combined with a BCAA-rich elemental diet reduces the risk of NAFLD after PD.

Pancreatic enzymes prepared in bicarbonate solution for administration through enteral feeding tubes.

PURPOSE: The dissolution and physicochemical effects of preparing delayed-release pancrelipase in a sodium bicarbonate solution before administration via an enteral feeding tube were studied. METHODS: Several doses of four delayed-release pancrelipase products (Creon, Pancreaze, Ultresa, Zenpep) were studied. The intact contents of pancrelipase capsules was added to 20 mL of 8.4% sodium bicarbonate solution to dissolve the enteric coating and liberate the enzymes into solution. In addition to visual observation, the pH, relative particle count, and osmolality of each admixture were assessed immediately and 5, 10, 20, and 30 minutes after admixture preparation. RESULTS: The only dose of Creon that was completely dissolved at 30 minutes was the 24,000 lipase unit dose. None of the doses of Pancreaze and only the lowest dose (23,000 lipase units) of Ultresa were completely dissolved at 30 minutes. However, Zenpep doses of 20,000 and 40,000 lipase units were completely dissolved 30 minutes after preparation. Higher doses of each pancrelipase product did not completely dissolve. The baseline pH of the solvent decreased slightly at the first few time points after pancrelipase was added. The relative particle count increased over time and with increasing doses. The osmolality of the mixtures varied by pancrelipase product. CONCLUSION: The dissolution of enteric coated granules in sodium bicarbonate varied with the pancrelipase product and dose. Zenpep 40,000 lipase units was found to most efficiently dissolve in sodium bicarbonate, possibly due to the consistent size of the product's granules and visibly thinner and uniform enteric coating.

Administration of Pancrelipase as Effective Treatment for Hepatic Steatosis After Pancreatectomy.

OBJECTIVES: To evaluate the incidence of hepatic steatosis after pancreatectomy and whether pancrelipase improves steatosis more effectively than other conventional digestive enzymes. METHODS: Patients who underwent distal pancreatectomy, pancreaticoduodenectomy (PD), or total pancreatectomy (TP) from August 2008 to July 2013 were included. Incidence of newly developed hepatic steatosis recognized by computed tomography and outcomes by treatment with pancrealipase or other enzymes were evaluated. RESULTS: A total of 473 patients were evaluated. Among 366 patients who did not take any digestive enzymes until the recognition of steatosis or the last follow-up date, hepatic steatosis was recognized in 3% (4/130), 17% (38/229), and 45% (3/7) of patients after distal pancreatectomy, PD, and TP, respectively, during the median follow-up of 641 days. Seventy patients including 25 patients taking digestive enzymes showed hepatic steatosis and were treated with pancrelipase (20 patients), other enzymes (19 patients), or no enzyme (31 patients). Cumulative improvement rate after 1 year of treatment in the 3 groups was 92%, 51%, and 56%, respectively, and that of the pancrelipase group was significantly better than the other 2 groups. CONCLUSION: The risk of hepatic steatosis should be a concern after PD and TP. Treatment with pancrelipase was more effective compared to other enzymes.

The effect of oral pancreatic enzyme supplementation on the course and outcome of acute pancreatitis: a randomized, double-blind parallel-group study.

CONTEXT: Pancreatic exocrine insufficiency is a significant problem after acute pancreatitis. OBJECTIVE: To evaluate whether oral pancreatic enzyme supplementation improves the recovery of pancreatic exocrine function and to explore the efficacy, safety and tolerability of pancreatic enzyme supplementation in patients during the refeeding period after acute pancreatitis. DESIGN: Prospective double-blind, placebo controlled, randomized study. PATIENTS: The sudy included 56 patients with acute pancreatitis. MAIN OUTCOME MEASURES: Primary efficacy variable was recovery from pancreatic exocrine insufficiency. Secondary objectives were body weight, abdominal pain, course of APACHE II score, patient's symptoms and quality of life. RESULTS: Twenty of the 56 patients showed low fecal elastase values indicating pancreatic exocrine insufficiency after acute pancreatitis. Median time to recovery from exocrine pancreatic insufficiency was 14 days in the enzyme supplementation group and 23 days in the placebo group but overall differences for primary and all but one secondary endpoint did not reach statistical significance. However, a positive tendency in favour of enzyme supplementation was found for quality of life parameters (FACT-Pa) in all subscores. There were no relevant differences between placebo and oral pancreatic enzyme supplementation detected with respect to safety and tolerability. CONCLUSION: Enzyme supplementation positively effects the course of acute pancreatitis if administered during the early refeeding phase after acute pancreatitis. There is evidence that oral pancreatic enzyme supplementation has a positive impact on the course of the disease and the global health status (less weight loss, less flatulence, improved quality of life). Oral pancreatic enzyme supplementation was safely administered and can be added to the treatment regimen of patients in a refeeding status after severe acute pancreatitis.

Pancreatic enzyme supplementation improves the incretin hormone response and attenuates postprandial glycemia in adolescents with cystic fibrosis: a randomized crossover trial.

CONTEXT: Cystic fibrosis-related diabetes is characterized by postprandial, rather than fasting, hyperglycemia. Gastric emptying and the release of the incretin hormones [glucagon-like peptide-1 (GLP-1) and glucose dependent insulinotropic polypeptide (GIP)] are central to postprandial glycemic control. Lipolysis is required for fat to slow gastric emptying and stimulate incretin release. OBJECTIVE: We aimed to determine the effect of pancreatic enzyme replacement therapy (PERT) on postprandial glycemia in adolescents with cystic fibrosis (CF). DESIGN: This was a double-blinded randomized crossover trial. Subjects consumed a high-fat pancake, with either PERT (50 000 IU lipase) or placebo. Gastric emptying was measured by a breath test and blood sampled frequently for plasma blood glucose, insulin, glucagon, GLP-1, and GIP. Data were also compared with seven healthy subjects. PARTICIPANTS: Fourteen adolescents (13.1 ± 2.7 y) with pancreatic-insufficient CF and seven healthy age-matched controls participated in the study. MAIN OUTCOME MEASURE: Postprandial hyperglycemia was measured as peak glucose and area under the curve for blood glucose at 240 minutes. RESULTS: CF subjects had postprandial hyperglycemia compared with controls (area under the curve, P < .0001). PERT reduced postprandial hyperglycemia (P = .0002), slowed gastric emptying (P = .003), and normalized GLP-1 and GIP secretion (P < .001 for each) when compared with placebo, without affecting insulin. CONCLUSION: In young people with pancreatic insufficient CF, PERT markedly attenuates postprandial hyperglycemia by slowing gastric emptying and augmenting incretin hormone secretion.

Efficacy of a Creon delayed-release pancreatic enzyme protocol for clearing occluded enteral feeding tubes.

BACKGROUND: Alkalinized Viokase pancreatic enzyme tablets restored patency to 71.9% of occluded Dobhoff tubes in a prospective study. After removal of Viokase tablets from the US market, the hospital protocol for unclogging enteral feeding tubes was adapted to use Creon pancreatic enzyme delayed-release capsules, despite the lack of published data. OBJECTIVE: To evaluate the effectiveness of a Creon-based protocol to clear occluded enteral feeding tubes. METHODS: This retrospective study included all adult and pediatric patients seen in the emergency department or in an inpatient setting who received Creon 12 000 units lipase delayed-release capsule dissolved in a solution of sodium bicarbonate 650 mg and sterile water for clearing occluded enteral feeding tubes between May 1 and November 30, 2010. The Creon protocol was deemed effective if tube clearance was documented in the medical record or if enteral feedings were resumed with no note regarding tube replacement. RESULTS: Alkalinized Creon delayed-release capsules were administered to 83 patients with a total of 118 clogged tubes. Three poorly documented cases and 5 tubes with mechanical clogs were excluded from data analysis. Patency was restored to 53 of 110 (48.2%) occluded tubes. More than 1 treatment course was attempted in 5 cases, with success in 3. CONCLUSION: An alkalinized Creon pancreatic enzyme protocol was effective in clearing approximately half of the occluded enteral feeding tubes in this retrospective study, an efficacy rate much less than that previously reported in the literature with a Viokase-based protocol.