Study of the gastrointestinal bioavailability of a pancreatic extract product (Zenpep) in chronic pancreatitis patients with exocrine pancreatic insufficiency.

INTRODUCTION: The Food and Drug Administration in 2006 required that all pancreatic enzyme products demonstrate bioavailability of lipase, amylase, and protease in the proximal small intestine. METHODS: In this phase I open-label, randomized, crossover trial, 17 adult chronic pancreatitis (CP) patients with severe exocrine pancreatic insufficiency (EPI) underwent two separate gastroduodenal perfusion procedures (Dreiling tube suctioning and [14C]-PEG instillation by an attached Dobhoff tube in the duodenal bulb). Patients received Ensure Plus® alone and Ensure Plus with Zenpep (75,000 USP lipase units) in random order. The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions. 14C-PEG was used to correct duodenal aspirates volume. The primary efficacy endpoint was lipase delivery in the duodenum after Zenpep administration under fed conditions. Secondary efficacy endpoints included chymotrypsin and amylase delivery, serum CCK levels, and measuring duodenal and gastric pH. RESULTS: Zenpep administration with a test meal was associated with significant increase in duodenal aspiration of lipase (p = 0.046), chymotrypsin (p = 0.008), and amylase (p = 0.001), compared to the test meal alone, indicating release of enzymes to the duodenum. Lipase delivery was higher in the pH subpopulation (the efficacy population with acid hypersecretors excluded) (p = 0.01). Recovery of [14C]-PEG was 61%. Zenpep was generally well tolerated. All adverse events were mild and transient. CONCLUSIONS: In CP patients with severe EPI, lipase, chymotrypsin and amylase were released rapidly into the duodenum after ingestion of Zenpep plus meal compared to meals alone. Results also reflected the known pH threshold for enzyme release from enteric coated products.

Predisposing factors for positive D-Xylose breath test for evaluation of small intestinal bacterial overgrowth: a retrospective study of 932 patients.

AIM: To investigate, in the largest cohort to date, patient characteristics and associated risk factors for developing small intestinal bacterial overgrowth (SIBO) using the D-Xylose breath test (XBT). METHODS: We performed a retrospective cross-sectional study to analyze patient characteristics who underwent the XBT for evaluation of SIBO. Diagnostic testing with the XBT was performed based on a clinical suspicion for SIBO in patients with symptoms of bloating, abdominal pain, abdominal distension, weight loss, diarrhea, and/or constipation. Consecutive electronic medical records of 932 patients who completed the XBT at the University of Florida between 2005 and 2009 were reviewed. A two-way Analysis of Variance (ANOVA) was used to test for several associations including age, gender, and body mass index (BMI) with a +XBT. A two-way ANOVA was also performed to control for the differences and interaction with age and between genders. A similar analysis was repeated for BMI. Associations between medical conditions and prior surgical histories were conducted using the Mantel-Haenszel method for 2 by 2 contingency tables, stratified for gender. Reported odds ratio estimates reflect the odds of the prevalence of a condition within the +XBT group to that of the -XBT group. P values of less than 0.05 (two-sided) were considered statistically significant. RESULTS: In the 932 consecutive eligible subjects studied, 513 had a positive XBT. A positive association was found between female gender and a positive XBT (P = 0.0025), and females with a positive test were, on average, greater than 5 years older than those with a negative test (P = 0.024). The mean BMI of positive XBT subjects was normal (24.5) and significantly lower than the subjects with a negative XBT (29.5) (P = 0.0050). A positive XBT was associated with gastroesophageal reflux disease (GERD) (OR = 1.35; 95%CI: 1.02-1.80, P = 0.04), peptic ulcer disease (PUD) (OR = 2.61; 95%CI: 1.48-4.59, P < 0.01), gastroparesis (GP) (OR = 2.04; 95%CI: 1.21-3.41, P < 0.01) and steroid use (OR = 1.35; 95%CI: 1.02-1.80, P = 0.01). Irritable bowel syndrome, independent proton-pump inhibitor (PPI) usage, or previous abdominal surgery was not significantly associated with a positive XBT. No single subdivision by gender or PPI use was associated with a significant difference in the odds ratios between any of the subsets. CONCLUSION: Female gender, lower BMI, steroid use, PUD, GERD (independent of PPI use), and GP were more prevalent in patients with SIBO, determined by a positive XBT. Increasing age was associated with SIBO in females, but not in males.

American Pancreatic Association Practice Guidelines in Chronic Pancreatitis: evidence-based report on diagnostic guidelines.

The diagnosis of chronic pancreatitis remains challenging in early stages of the disease. This report defines the diagnostic criteria useful in the assessment of patients with suspected and established chronic pancreatitis. All current diagnostic procedures are reviewed, and evidence-based statements are provided about their utility and limitations. Diagnostic criteria for chronic pancreatitis are classified as definitive, probable, or insufficient evidence. A diagnostic (STEP-wise; survey, tomography, endoscopy, and pancreas function testing) algorithm is proposed that proceeds from a noninvasive to a more invasive approach. This algorithm maximizes specificity (low false-positive rate) in subjects with chronic abdominal pain and equivocal imaging changes. Furthermore, a nomenclature is suggested to further characterize patients with established chronic pancreatitis based on TIGAR-O (toxic, idiopathic, genetic, autoimmune, recurrent, and obstructive) etiology, gland morphology (Cambridge criteria), and physiologic state (exocrine, endocrine function) for uniformity across future multicenter research collaborations. This guideline will serve as a baseline manuscript that will be modified as new evidence becomes available and our knowledge of chronic pancreatitis improves.

A pilot retrospective study of the relationship between estrogen use and pancreatitis/pancreatic function in women with chronic abdominal pain.

CONTEXT: Estrogens are thought to cause pancreatitis by raising triglyceride levels but whether there are other effects on the pancreas is debatable. OBJECTIVE: To better elucidate the relationship between estrogens and pancreatitis and pancreatic function in a pilot study. DESIGN/SETTING/PATIENTS: Our retrospectively collected database of 224 patients who had undergone secretin stimulation testing was queried for females with available medication histories, who were then divided into two groups: those taking estrogens (E) and those not on estrogens (N). Mann Whitney U and Fisher's exact tests were used. RESULTS: Seventy of the patients in the database were females with available medication histories. Thirty-five (50.0%) were taking estrogens. Twenty-nine (82.9%) of the E patients experienced any type of pancreatitis (i.e., acute pancreatitis, acute relapsing pancreatitis, chronic pancreatitis) while only 19 (54.3%) of the N patients did (P=0.019). During secretin stimulation testing, the peak bicarbonate levels for E and N patients were 80±18 and 90±23 mEq/L, respectively (P=0.058). When patients with any type of pancreatitis were excluded, E patients still displayed decreased peak bicarbonate levels in response to secretin (90±18 vs. 104±19 mEq/L; P=0.021). Weight, age, triglyceride levels, frequency of patients with cholecystectomy and biliary stones did not significantly differ between the two groups (E and N respectively). CONCLUSIONS: These pilot data suggest exogenous estrogens may be related to the development of acute pancreatitis and acute relapsing pancreatitis, and probably to a lesser degree chronic pancreatitis, perhaps through a triglyceride independent mechanism. During secretin stimulation testing, peak bicarbonate production may be diminished in women on estrogens (even in those who have never had pancreatitis). Further study is necessary to better define the relationship between estrogen use, pancreatitis, and pancreatic function.

The significance of the volume of pancreatic juice measured at secretin stimulation testing: a single-center evaluation of 224 classical secretin stimulation tests.

OBJECTIVES: (1) To quantitate volume production during secretin stimulation testing in patients suspected of having chronic pancreatitis (CP); (2) to compare volume production to clinical criteria for the diagnosis of CP. METHODS: A total of 224 patients referred for suspected CP were reviewed retrospectively for clinical information supporting the diagnosis of CP. The patients were divided into 2 groups: those with peak bicarbonate (PB) of less than 80 mEq/L and those with PB of 80 mEq/L or greater (ie, CP and no CP). For a separate comparison, the patients were also placed into similar 2 groups based on clinical criteria. The volume, total bicarbonate output, volume per kilogram, and PB of pancreatic juice after secretin stimulation in patients thought to have CP were compared to those thought not to have CP. RESULTS: Volume was lower in the patients with PB of less than 80 mEq/L (206 ± 114 and 269 ± 106 mL) and lower in patients who met clinical criteria for CP (203 ± 109 and 271 ± 108 mL), P < 0.001 for both, but there was significant overlap (volume alone did not accurately discriminate CP from no CP). CONCLUSIONS: During secretin stimulation testing, bicarbonate parameters likely are better predictors of CP than volume parameters. Changes in the production of the volume of pancreatic juice during secretin stimulation likely reflect relatively late changes in pancreatic function.

Effect of azithromycin on small bowel motility in patients with gastrointestinal dysmotility.

OBJECTIVE: To investigate the effect of azithromycin (AZI) on small bowel activity in patients with gastrointestinal dysmotility (GID). MATERIAL AND METHODS: Manometric data on a consecutive series of 21 patients was reviewed. Only those patients with gastroparesis and small bowel dysmotility as defined by antroduodenal manometric criteria were included. Pressure profiles were recorded in three stages: baseline period, fed state and postprandial after administration of erythromycin (ERY) and AZI. The measured parameters included the number and characteristics of activity fronts and migrating motor complexes (MMCs) including duration, amplitude and frequency of contractions. The data were analyzed using repeated measures analysis of variance for comparison of each medication. RESULTS: AZI induced more MMCs in the duodenum with origin of activity fronts in the antrum than did ERY (18 patients with AZI, 10 patients with ERY). No significant difference between AZI and ERY was seen with respect to the amplitude of MMCs or number of cycles per minute. The average duration of activity fronts was longer with AZI compared with ERY (AZI mean 18.5 min, ERY mean 9.7 min, p < 0.02). CONCLUSIONS: AZI induces activity fronts in the antrum followed by duodenal contractions more frequently than ERY in patients with GID. AZI potentially promises to be a prokinetic for treatment of small bowel dysmotility.

A new 13C breath test to detect vitamin B12 deficiency: a prevalent and poorly diagnosed health problem.

Vitamin B12 deficiency is emerging as a growing public health problem. The most commonly used diagnostic tests are limited in accuracy, sensitivity, and are non-specific for B12 deficiency. The aim of this study was to develop a simple B12 breath test (BBT) to more accurately evaluate vitamin B12 status as an alternative to the most common diagnostic test, serum B12 levels. The breath test is based on the metabolism of sodium 1-(13)C-propionate to (13)CO(2) which requires B12 as a cofactor. We initially compared the BBT to current B12 diagnostic methods in 58 subjects. Subjects also received a second BBT 1-3 days after initial testing to evaluate reproducibility of results. Propionate dosage, fasting times, and collection periods were compared, respectively. The dose of sodium 1-(13)C-propionate (10-50 mg) gave equivalent results while an 8 h fast was essential. Statistical analysis revealed that breath collection times could be reduced to just a baseline and 10 and 20 min following propionate dosing. We also measured the incidence of B12 deficiency with the BBT in 119 patients with chronic pancreatitis, Crohn's disease, small intestinal bacterial overgrowth, and subjects over 65 years of age. The BBT results agreed with previous publications showing a higher incidence of B12 deficiency in these patients. The BBT may provide clinicians with a non-invasive, accurate, reliable, and reproducible diagnostic test to detect vitamin B12 deficiency.

Efficacy of a novel pancreatic enzyme product, EUR-1008 (Zenpep), in patients with exocrine pancreatic insufficiency due to chronic pancreatitis.

OBJECTIVES: EUR-1008 (ZENPEP® [pancrelipase] Delayed-Release Capsules) delayed-release capsules is a novel, enteric-coated, porcine-derived pancreatic enzyme product. This study evaluated the efficacy and safety of 2 doses of ZENPEP in patients with chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI). METHODS: The effect of ZENPEP on the coefficient of fat absorption (CFA) was investigated in a randomized, double-blind, dose-response, crossover study with placebo run-in (7-9 days) and 2 treatment periods (9-11 days) composed of a high dose (7 × 20,000 lipase units per day) and a low dose (7 × 5000 lipase units per day). RESULTS: Mean CFA was significantly higher with low- (88.9%) and high-dose (89.9%) ZENPEP versus placebo run-in (82%; P < 0.001; n = 72) with no difference between doses (P = 0.228, primary end point). In patients with baseline CFA less than 90% (n = 33), the high dose was significantly more effective (CFA: 84.1%) than the low dose (CFA: 81.1%; P < 0.001). Post hoc analysis revealed an increase in treatment effect with more severe EPI. Coefficient of nitrogen absorption (P < 0.001), body weight (P ≤ 0.021), and body mass index (P ≤ 0.020) also increased significantly with both doses compared with baseline. Percentage of days with EPI symptoms decreased with both doses. CONCLUSIONS: Our findings suggest that CP patients with EPI benefit from a low dose of ZENPEP, whereas the high dose might be needed for patients with more severe EPI.

Advantages of azithromycin over erythromycin in improving the gastric emptying half-time in adult patients with gastroparesis.

BACKGROUND/AIMS: Current therapy for gastroparesis with prokinetic agents is limited by options and side effects. One macrolide, erythromycin (ERY), is associated with possible sudden cardiac death from QT prolongation due to P450 iso-enzyme inhibition. An alternative, azithromycin (AZI), lacks P450 inhibition. We compared the effect on gastric emptying half-times (t½) between AZI and ERY in patients diagnosed with gastroparesis by gastric emptying scintigraphy. METHODS: Patients stopped medications known to affect gastric emptying prior to the study, and then ingested 1 scrambled egg meal labeled with 18.5-37 MBq of technetium-99m sulfur colloid followed by continuous imaging for 120 minutes, at 1 minute per frame. A simple linear fit was applied to the rate of gastric emptying, and gastric emptying t½ was calculated (normal = 45-90 minutes). At 75-80 minutes, if the stomach had clearly not emptied, patients were given either ERY (n = 60) or AZI (n = 60) 250 mg IV and a new post-treatment gastric emptying t½ was calculated. RESULTS: Comparison of gastric emptying t½ showed a similar positive effect (mean gastric emptying t½ for AZI = 10.4 ± 7.2 minutes; mean gastric emptying t½ for ERY = 11.9 ± 8.4 minutes; p = 0.30). CONCLUSIONS: AZI is equivalent to ERY in accelerating the gastric emptying of adult patients with gastroparesis. Given the longer duration of action, better side effect profile and lack of P450 interaction for AZI as compared with ERY, further research should evaluate the long term effectiveness and safety of AZI as a gastroparesis treatment.

Screening and therapy for malnutrition and related gastro-intestinal disorders in systemic sclerosis: recommendations of a North American expert panel.

OBJECTIVES: To develop a set of recommendations for clinicians caring for patients with systemic sclerosis (SSc) to guide their approach to the patient with malnutrition and possible malabsorption. METHODS: The Canadian Scleroderma Research Group convened a meeting of experts in the areas of nutrition, speech pathology, oral health in SSc, SSc and gastroenterology to discuss the nutrition-GI paradigm in SSc. This meeting generated a set of recommendations based on expert opinion. RESULTS: Physicians should screen ALL patients with SSc for malnutrition. The physician should ask a series of questions that pertain to GI involvement. Patients who screen positive for malnutrition should be referred to a dietitian and gastroenterologist. Referral to a patient support group should be considered and if screening reveals oral health problems, referral to a dentist, preferably with expertise in treating patients with SSc, should be done. All SSc patients should weigh themselves monthly and report any sudden significant changes in weight. They should be assessed by a rheumatologist once a year for signs of malnutrition. CONCLUSIONS: Malnutrition may be common in SSc and a multidisciplinary approach is important.

The management of acute and chronic pancreatitis.

Pancreatitis, which is most generally described as any inflammation of the pancreas, is a serious condition that manifests in either acute or chronic forms. Chronic pancreatitis results from irreversible scarring of the pancreas, resulting from prolonged inflammation. Six major etiologies for chronic pancreatitis have been identified: toxic/ metabolic, idiopathic, genetic, autoimmune, recurrent and severe acute pancreatitis, and obstruction. The most common symptom associated with chronic pancreatitis is pain localized to the upper-to-middle abdomen, along with food malabsorption, and eventual development of diabetes. Treatment strategies for acute pancreatitis include fasting and short-term intravenous feeding, fluid therapy, and pain management with narcotics for severe pain or nonsteroidal anti-inflammatories for milder cases. Patients with chronic disease and symptoms require further care to address digestive issues and the possible development of diabetes. Dietary restrictions are recommended, along with enzyme replacement and vitamin supplementation. More definitive outcomes may be achieved with surgical or endoscopic methods, depending on the role of the pancreatic ducts in the manifestation of disease.

Comparison of the effect of azithromycin versus erythromycin on antroduodenal pressure profiles of patients with chronic functional gastrointestinal pain and gastroparesis.

BACKGROUND: Current pharmacologic treatments for gastroparesis have been disappointing due to the limited options available. Erythromycin ethylsuccinate is a potent prokinetic agent that stimulates gastric emptying. Recently, erythromycin has been linked to the occurrences of sudden cardiac death due to QT prolongation. Azithromycin is similar to erythromycin in structure but does not have significant drug-drug interactions as seen with erythromycin. PURPOSE: This study aims to determine whether azithromycin stimulates antral activity in patients with chronic gastrointestinal pain and refractory gastroparesis. METHODS: Small bowel manometric data on 30 patients undergoing clinical evaluation for chronic digestive problems or documented refractory gastroparesis were reviewed. Antral activity was measured after infusion of erythromycin 250 mg intravenous and azithromycin (500 or 250 mg intravenous) given at different intervals during the small bowel manometry. The parameters measured included the total duration of effect, mean amplitude of antral contractions, duration of the highest antral contraction phase, number of cycles per minute, and the motility index. RESULTS: Comparison of erythromycin and azithromycin at similar doses showed a similar positive effect on antral activity. However, comparison of erythromycin and azithromycin at the higher dose of 500 mg showed that the mean amplitude, duration of antral activity, and motility index were significantly increased with azithromycin (P < 0.05). CONCLUSIONS: Azithromycin stimulates antral activity similar to erythromycin and moreover has a longer duration of effect. However, unlike erythromycin, azithromycin does not have significant drug-drug interactions and maybe a potential new medication for the treatment of gastroparesis and gastrointestinal dysmotility.

A pilot study of Octreotide LAR vs. octreotide tid for pain and quality of life in chronic pancreatitis.

CONTEXT: Chronic abdominal pain is the most difficult management issue in patients with chronic pancreatitis. Recently, a long-acting depo-formulated version of octreotide has been developed that can be given as a once monthly intramuscular injection, Octreotide LAR(R) (O-LAR) rather than as a thrice daily subcutaneous injection (octreotide short-acting, O-SA). OBJECTIVE: To see if O-LAR is similar in efficacy to O-SA in the treatment of painful chronic pancreatitis in a small open-label, unblinded pilot study. PATIENTS: Seven advanced chronic pancreatitis patients with daily, severe abdominal pain who had previously responded to O-SA were recruited from the pancreas clinics of the University of Florida and monitored for one month on O-SA and for four months while on O-LAR. Each patient served as his/her own control as this was a paired data set. MAIN OUTCOME MEASURES: 1) Daily VAS scores; 2) daily morphine equivalents; 3) monthly health related quality of life chronic pancreatitis surveys; 4) daily diaries of work/pleasurable activities missed or hospitalization/Emergency Department visits. RESULTS: Average daily VAS scores for patients during O-SA therapy were 4.50+/-2.28 and during the fourth month of O-LAR therapy, 3.86+/-2.11, difference -0.64+/-0.80 (P=0.078). Average daily morphine equivalents were not dissimilar at 124.3+/-177.3 mg during O-SA therapy and 131.6+/-194.3 mg during O-LAR therapy; difference 7.3+/-17.5 mg P=0.310. Health related quality of life chronic pancreatitis scores were not significantly changed when moving from O-SA to O-LAR. Adverse events were rare. CONCLUSIONS: Octreotide LAR(R) may be a reasonable substitute for tid octreotide in treating chronic pancreatitis pain. Further, larger studies would be useful to better characterize the role of Octreotide LAR(R) in the management of chronic pancreatitis pain.

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

OBJECTIVES: Creon 10 Minimicrospheres is an enteric-coated, delayed-release pancrelipase preparation designed to deliver active pancreatic enzymes to the small intestine. The primary objective of this study was to compare the effect of Creon 10 with placebo in the control of steatorrhea in chronic pancreatitis patients. Secondary objectives included evaluation of stool parameters and global improvement of symptoms scales. METHODS: The study was a randomized, double-blind, placebo-controlled, 2-week trial. After a placebo run-in ("washout") phase, the effect on coefficient of fat absorption (%), daily fat excretion before and after treatment, and stool frequency and consistency were assessed. RESULTS: In Creon 10-treated subjects, the change in mean coefficient of fat absorption (%) from run-in to double-blind phase was significantly higher compared with placebo-treated subjects (+36.7 vs. +12.1, P = 0.0185). Stool consistency improved significantly more with Creon 10 than with placebo (P = 0.0102) resulting in more subjects with formed stool; stool frequency decreased significantly more with Creon 10 than with placebo (P = 0.0015) from 10.8 during placebo run-in to 5.2 stools per day during double-blind treatment; and daily mean fat excretion in stool decreased significantly more (-56.5 vs. -11.4 g/d, P = 0.0181) in Creon 10-treated subjects compared with placebo-treated subjects. Global disease symptom scores showed greater improvement for both physicians and subjects in the Creon 10 group relative to those receiving placebo. Between treatment difference reached statistical significance for Creon 10 (P = 0.0435) for physician score and showed a trend (P = 0.0634) favoring Creon for subject score. CONCLUSIONS: This randomized, placebo-controlled trial found that Creon 10 treatment controlled steatorrhea, as reflected in reduced fat excretion, decreased stool frequency and improved stool consistency. Creon 10 treatment was safe and well tolerated.

Comparative analysis of direct pancreatic function testing versus morphological assessment by endoscopic ultrasonography for the evaluation of chronic unexplained abdominal pain of presumed pancreatic origin.

OBJECTIVES: The diagnosis of "minimal change" chronic pancreatitis (MCCP) is often considered when conventional imaging studies are unrevealing in a patient population with abdominal pain of presumed pancreatic origin. Direct pancreatic function testing using secretin as a secretagogue (ST) has been considered the most sensitive method to diagnose MCCP but is not widely available to clinicians. Endoscopic ultrasound (EUS) allows detailed imaging of pancreatic architecture, but the sensitivity and specificity for MCCP remain to be determined. We sought to compare the accuracy of EUS and ST in patients with presumed MCCP. METHODS: Seventy-four patients referred to our pancreas clinic with unexplained abdominal pain and previously negative imaging studies underwent an ST for evaluation of possible MCCP. Twenty-one of these also underwent EUS. EUS images were read by 1 of 2 experts blinded to ST results. RESULTS: Using ST as the "gold standard," EUS had a maximum sensitivity of 71% when the cut-off for diagnosis was set at at least 3 EUS features. Conversely, maximum specificity (92%) was seen when the cut-off value was set at at least 6 EUS criteria. Diagnostic certainty was only 50% (positive predictive value = 0.5) when at least 6 criteria were used as the cut-off. MCCP was excluded with greater than 70% certainty when less than 3 criteria were present. At the best cut-off value of at least 4 features, EUS had a sensitivity of 57% and a specificity of 64%. CONCLUSIONS: In this patient population with abdominal pain of presumed pancreatic origin, EUS and standard pancreatic function testing are often discordant. If ST is assumed to be the reference against which other tests are compared, EUS is less accurate than ST in diagnosing MCCP.

Small Bowel Bacterial Overgrowth: Presentation, Diagnosis, and Treatment.

Small bowel bacterial overgrowth (SBBO) syndrome is associated with excessive numbers of bacteria in the proximal small intestine. The pathology of this condition involves competition between the bacteria and the human host for ingested nutrients. This competition leads to intraluminal bacterial catabolism of nutrients, often with production of toxic metabolites and injury to the enterocyte. A complex array of clinical symptoms ensues, resulting in chronic diarrhea, steatorrhea, macrocytic anemia, weight loss, and less commonly, protein-losing enteropathy. Therapy is targeted at correction of underlying small bowel abnormalities that predispose to SBBO and appropriate antibiotic therapy. The symptoms and signs of SBBO can be reversed with this approach.

Is a 15-minute collection of duodenal secretions after secretin stimulation sufficient to diagnose chronic pancreatitis?

BACKGROUND: Standard hormonal stimulation tests of pancreatic function use a 60- to 90-minute collection of pancreatic secretions. A shorter 15-minute collection time has been proposed to increase the feasibility of the secretin stimulation test. The accuracy of this brief collection period for the diagnosis of chronic pancreatitis has not been well defined. METHODS: We retrospectively evaluated the accuracy of a 15-minute collection period by comparing the results of 633 complete standard secretin tests (60 minutes) to the result using only the first 15-minute collection of the same test. The gold standard used for the diagnosis of chronic pancreatitis was the final result of the complete 60-minute secretin stimulation test. RESULTS: The specificity of the first 15-minute collection was 34.6% (95% CI, 30.03%-39.21%). The positive predictive value was 44.9% (95% CI, 40.5%-49.3%). The accuracy was 57.3% (95% CI, 53.01% 59.34%). CONCLUSIONS: Using only the first 15-minute collection period in a standard 60-minute secretin test is inaccurate in the diagnosis of chronic pancreatitis.

Comparison of biologic porcine secretin, synthetic porcine secretin, and synthetic human secretin in pancreatic function testing.

BACKGROUND AND AIMS: Due to the unavailability of biologic porcine secretin (BPS), 2 synthetic forms of secretin were developed. Our aim is to determine the bioequivalency of the 3 forms of secretin in pancreatic function testing. METHODS: In a randomized, crossover design, synthetic porcine (SPS) and synthetic human secretin (SHS) were compared in a group of 12 subjects with chronic pancreatitis undergoing secretin stimulation test (SST). The 2 synthetic forms of secretin were then compared with BPS in 12 subjects utilizing a similar design. Finally, 18 healthy subjects underwent secretin stimulation testing with SHS. RESULTS: There was excellent correlation of peak bicarbonate measurements in the comparison of SPS to SHS (R = 0.967) as well as in the comparison of all 3 forms of secretin (P = 0.08, ANOVA for correlated samples). In the SST, each of the synthetic forms of secretin were 100% accurate in diagnosing chronic pancreatitis in disease subjects and in excluding chronic pancreatitis in normal controls. The synthetic forms of secretin were associated with fewer side effects when compared with BPS with the exception of transient tachycardia which occurred in up to 19% of subjects. CONCLUSIONS: The synthetic porcine and human forms of secretin are equivalent to one another and to biologic porcine secretin and can be used interchangeably in pancreatic function testing.