Faecal Elastase 1: Not Helpful in Diagnosing Chronic Pancreatitis Associated with Mild to Gut: First Published As 10.1136/Gut.42.4.551 on 1 April 1998
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Gut 1998;42:551–554 551 Faecal elastase 1: not helpful in diagnosing chronic pancreatitis associated with mild to Gut: first published as 10.1136/gut.42.4.551 on 1 April 1998. Downloaded from moderate exocrine pancreatic insuYciency P G Lankisch, I Schmidt, H König, D Lehnick, R Knollmann, M Löhr, S Liebe Abstract tion. The former is particularly helpful Background/Aim—The suggestion that only in detecting severe EPI, but not the estimation of faecal elastase 1 is a valuable mild to moderate form, which poses the new tubeless pancreatic function test was more frequent and diYcult clinical prob- evaluated by comparing it with faecal chy- lem and does not correlate significantly motrypsin estimation in patients catego- with the severe morphological changes rised according to grades of exocrine seen in chronic pancreatitis. pancreatic insuYciency (EPI) based on (Gut 1998;42:551–554) the gold standard tests, the secretin- pancreozymin test (SPT) and faecal fat Keywords: faecal elastase 1; faecal chymotrypsin; analysis. secretin-pancreozymin test; faecal fat analysis; exocrine pancreatic insuYciency; diagnosis Methods—In 64 patients in whom EPI was suspected, the following tests were per- formed: SPT, faecal fat analysis, faecal The diagnosis of chronic pancreatitis is usually chymotrypsin estimation, faecal elastase 1 based on abnormal results from pancreatic estimation. EPI was graded according to function tests and morphological examin- the results of the SPT and faecal fat ation.1 For the evaluation of exocrine pancre- analysis as absent, mild, moderate, or atic function, there are both direct and indirect severe. The upper limit of normal for fae- tests. The gold standard is the secretin- cal elastase 1 was taken as 200 µg/g, and for pancreozymin test (SPT) or one of its modifi- faecal chymotrypsin 3 U/g stool. Levels cations. However, these can only be carried out between 3 and 6 U/g stool for faecal at qualified gastroenterological centres since chymotrypsin are usually considered to be the test is time consuming, invasive, and http://gut.bmj.com/ suspicious for EPI. In this study, both 3 expensive.23 Therefore a number of indirect and 6 U/g stool were evaluated as the tests of pancreatic function that measure upper limit of normal. pancreatic enzymes in serum, such as pancre- Results—Exocrine pancreatic function was normal in 34 patients, of whom 94, 91, atic isoamylase and immunoreactive trypsin, or and 79% had normal faecal elastase 1 and split products in serum or urine, such as the faecal chymotrypsin levels (<3 U/g and <6 NBT-PABA test or the pancreolauryl test, or U/g) respectively. Thirty patients had EPI, faecal contents of enzymes, such as chymo- on September 24, 2021 by guest. Protected copyright. Department of of whom 53, 37, and 57% had abnormal trypsin, have been developed and evaluated for Internal Medicine, diagnosing exocrine pancreatic insuYciency Municipal Hospital of faecal enzyme levels (diVerences not sig- Lüneburg, Lüneburg, nificant). When EPI was graded as mild, (EPI). None has become an accepted gold Germany moderate, or severe, 63% of patients had standard for doctors in clinical practice outside P G Lankisch mild to moderate EPI, and 37% had severe of gastroenterological centres. Therefore the I Schmidt isolation of pancreatic elastase 1 and its further H König EPI. In the latter group, between 73 and 91% of patients had abnormal faecal characterisation as a human- and pancreas- Department for enzymes. In the group with mild to specific enzyme that is not degraded during Statistics and moderate EPI, abnormal test results were intestinal transport and that is enriched 5- to Econometrics, obtained for both faecal enzymes in less 6-fold in faeces compared with duodenal juice 4–6 University of than 50% of the patients (diVerences not is of interest. A highly sensitive enzyme Göttingen, Göttingen, linked immunosorbent assay (ELISA) for Germany significant). Some 40% of the patients had D Lehnick pancreatic calcifications. There were no human faecal and duodenal elastase 1 using significant diVerences for either faecal two specific monoclonal antibodies is commer- 4–6 7–10 University of Rostock, enzyme between the two groups with and cially available. Preliminary studies seem Rostock, Germany without pancreatic calcifications. In 62% to indicate that faecal elastase 1 estimation is a R Knollmann valuable test of pancreatic function and could M Löhr of the patients who underwent an endo- S Liebe scopic retrograde cholangiopancreatog- become a new gold standard indirect test of raphy (ERCP), abnormal duct changes pancreatic function.11 The aim of our study was Correspondence to: were found. Again, there were no signifi- to evaluate faecal elastase 1 estimations in Professor P G Lankisch, patients categorised according to grades of EPI Medizinische Klinik, cant diVerences for either faecal enzyme Staedtisches Krankenhaus, between the two groups with abnormal based on the gold standard tests, SPT and fae- Boegelstrasse 1, D-21339 and normal ERCP. cal fat analysis. Furthermore, we aimed to find Lueneburg, Germany. Conclusion—Estimation of faecal elastase out whether this new test is really better than Accepted for publication 1 is not distinctly superior to the the traditionally used estimation of faecal chy- 23 September 1997 traditional faecal chymotrypsin estima- motrypsin. 552 Lankisch, Schmidt, König, et al Table 1 Estimation of faecal elastase 1 and faecal chymotrypsin in patients with exocrine one or more enzymes; bicarbonate concentra- pancreatic insuYciency of varying severity tion and faecal fat excretion normal), moderate (reduced enzyme output and bicarbonate con- Abnormal faecal chymotrypsin centration; faecal fat excretion normal) or Gut: first published as 10.1136/gut.42.4.551 on 1 April 1998. Downloaded from Abnormal faecal elastase severe (reduced enzyme output and bicarbo- Number 1 (<200 µg/g stool) <3 U/g stool <6 U/g stool nate concentration plus steatorrhoea).313 For Exocrine pancreatic insuYciency morphological evaluation of the pancreas, a Absent 34 2 (6) 3 (9) 7 (21)* Present 30 16 (53) 11 (37) 17 (57)† plain abdominal x ray of the pancreatic area or an ultrasound examination of the pancreas was Mild 10 4 (40) 1 (10) 3 (30)‡ performed to detect pancreatic calcifications in Moderate 9 3 (33) 2 (22) 4 (44)§ Severe 11 9 (82) 8 (73) 10 (91)¶ patients with EPI. In addition, an endoscopic retrograde cholangiopancreatography (ERCP) Values in parentheses are percentages. was performed when indicated; the results were Faecal elastase 1 v faecal chymotrypsin <3 U/g stool and <6 U/g stool (McNemar test): *p=1, p=0.18, NS; †p=0.13, p=1, NS; ‡p=0.25, p=1, NS; §p=1, p=1, NS; ¶p=1, p=1, NS. expressed in terms of the Cambridge classification.15 16 For statistical evaluation of Table 2 Estimation of faecal elastase 1 and faecal chymotrypsin in patients with the test results, sensitivity and specificity rates compensated (no steatorrhoea) and decompensated (steatorrhoea) exocrine pancreatic insuYciency as well as the McNemar and the Fisher’s exact tests were used. Abnormal faecal chymotrypsin Results Abnormal faecal elastase Number 1 (<200 µg/g stool) <3 U/g stool <6 U/g stool Faecal elastase 1 was abnormal in two (6%) of 34 patients with non-pancreatic disease and a Steatorrhoea Absent 19 7 (37) 3 (16) 7 (37) normal SPT, and faecal chymotrypsin was Present 11 9 (82)* 8 (73)† 10 (91)‡ abnormal in three (9%) and seven (21%) of these patients, taking 3 and 6 U/g stool respec- Values in parentheses are percentages. *p=0.03, †p=0.004, ‡p=0.03. tively as the upper limit of normal. Thus the specificity of the elastase 1 determination was Methods 94%, and that for chymotrypsin 91 and 79%, Exocrine pancreatic function was tested in 64 depending on the upper limit of normalcy patients sent to our department within 24 (table 1; McNemar test: p = 1 and p = 0.18, months with suspected EPI by means of diVerences not significant). Faecal elastase 1 SPT,12 13 quantitative faecal fat analysis,14 and was abnormal in 16 (53%) and faecal chymo- faecal chymotrypsin (Boehringer-Mannheim, trypsin in 11 (37%) and 17 (57%) of 30 Mannheim, Germany) and elastase 1 (Schebo- patients with EPI (McNemar test: p = 0.13 and Tech, D-35435 Wettenberg, Germany) estima- p = 1, not significant; table 1). When patients tions. The latter three tests were performed on were graded into groups of diVerent degrees of http://gut.bmj.com/ three stool samples collected over 24 hours for EPI, 10 had mild, 9 moderate, and 11 severe three days, and mean values were determined. insuYciency. In the severe group, the percent- Normal values were: (a) SPT: after secretin ages of abnormal test results were high, with administration, fluid secretion >67 ml/30 min, 82% abnormal results for elastase 1 and 73 and bicarbonate concentration >70 mmol/l, bicar- 91% for chymotrypsin estimations for the two bonate output >6.5 mmol/30 min; after lower limits of normal. However, in the groups cholecystokinin-pancreozymin administration, with mild and moderate EPI, abnormal test amylase output >12 000 U/30 min, lipase out- results were observed in less than 50% of the on September 24, 2021 by guest. Protected copyright. put >65 000 U/30 min, and trypsin output >30 patients (table 1; diVerences not significant for U/30 min; (b) faecal fat <7 g/day; (c) faecal any stage; McNemar test, faecal elastase 1 v elastase 1 >200 µg/g stool; (d) faecal chymo- faecal chymotrypsin <3 U/g, p = 0.25, p = 1 trypsin <3 U/g stool. Since values between 3 andp=1,and<6U/g,p=1,p=1,p=1). and 6 U/g are indicative of EPI, both When patients were divided into two groups measurements—that is, 3 and 6 U/g stool— according to the presence or absence of were taken as the upper limit of normal.